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Trial record 62 of 229 for:    "Depressive Disorder" [DISEASE] | ( Map: Missouri, United States )

A Study Comparing Duloxetine and Placebo in Assessing Energy and Vitality in Major Depressive Disorder (MDD) Patients

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ClinicalTrials.gov Identifier: NCT00536471
Recruitment Status : Completed
First Posted : September 27, 2007
Results First Posted : July 17, 2009
Last Update Posted : November 20, 2009
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Duloxetine hydrochloride
Drug: Placebo
Enrollment 776
Recruitment Details  
Pre-assignment Details Study HMFS comprises two identical trials (identified as Group A and Group B). Study Period I was a screening period. Study Period II was a 9-month double-blind treatment period. Study Period III was an optional double-blind 2-week discontinuation/taper period.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Period Title: Overall Study
Started 257 127 261 131
Completed 101 43 122 57
Not Completed 156 84 139 74
Reason Not Completed
Lost to Follow-up             48             23             48             22
Adverse Event             32             16             28             13
Withdrawal by Subject             40             24             43             21
Lack of Efficacy             17             18             11             9
Protocol Violation             8             1             2             3
Physician Decision             11             1             3             2
Death             0             0             1             2
Sponsor Decision             0             1             3             2
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo Total
Hide Arm/Group Description duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD). Total of all reporting groups
Overall Number of Baseline Participants 257 127 261 131 776
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
42.2  (12.2) 43.7  (12.5) 44.7  (12.2) 43.9  (11.9) 43.6  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
Female
155
  60.3%
78
  61.4%
169
  64.8%
87
  66.4%
489
  63.0%
Male
102
  39.7%
49
  38.6%
92
  35.2%
44
  33.6%
287
  37.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
United States 249 123 222 110 704
Puerto Rico 8 4 39 21 72
History - Atypical Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
Yes 7 5 19 7 38
No 250 122 242 124 738
History - Melancholic Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
Yes 134 71 147 71 423
No 123 56 114 60 353
History - Seasonal Pattern in Major Depressive Disorder (MDD) if ≥3 Previous MDD Episodes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
Yes 3 3 9 4 19
No 220 105 232 112 669
Missing Response 34 19 20 15 88
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
African 63 36 30 16 145
Caucasian 160 73 172 81 486
Hispanic 29 11 55 30 125
East Asian 3 5 3 1 12
West Asian (Indian sub-continent) 2 2 1 2 7
Native American 0 0 0 1 1
Body Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
168.1  (10.1) 168.5  (9.2) 169.0  (9.7) 168.8  (9.4) 168.6  (9.7)
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
88.8  (23.7) 84.9  (22.5) 88.6  (26.6) 86.4  (23.5) 87.7  (24.5)
Evaluation - Brief Profile of Mood States (BPOMS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
Total Score 49.0  (19.2) 47.5  (18.7) 51.8  (19.3) 51.8  (18.7) 50.2  (19.1)
Tension-Anxiety Score 9.5  (4.6) 9.2  (4.6) 10.0  (5.0) 10.4  (4.6) 9.8  (4.7)
Depression-Dejection Score 11.8  (4.8) 11.5  (4.8) 12.3  (4.6) 12.0  (4.2) 12.0  (4.7)
Anger-Hostility Score 8.9  (5.4) 9.0  (5.4) 9.5  (5.1) 9.5  (5.4) 9.2  (5.3)
Vigor-Activity Score 3.4  (3.1) 3.9  (3.1) 3.6  (3.5) 3.4  (3.0) 3.5  (3.2)
Fatigue-Inertia Score 12.8  (4.6) 12.3  (4.8) 13.5  (4.7) 13.2  (4.5) 13.0  (4.7)
Confusion-Bewilderment Score 9.7  (4.0) 9.6  (3.9) 9.8  (4.1) 10.1  (3.8) 9.8  (4.0)
[1]
Measure Description: The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety, depression-dejection, anxiety-hostility, fatigue, confusion, and vigor. Item scores: 0 (not at all) to 4 (extremely). Each factor scores range from 0 to 20. The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig).
Evaluation - 16-Item Quick Inventory of Depressive Symptomatology (QIDS16) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
14.7  (4.1) 13.7  (4.4) 15.0  (4.4) 14.7  (3.8) 14.6  (4.2)
[1]
Measure Description: A 16-item patient-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Evaluation - 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
22.9  (4.3) 22.8  (3.7) 22.8  (4.5) 22.9  (4.9) 22.8  (4.4)
[1]
Measure Description: The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 10:Anxiety (Psychic)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
2.1  (0.8) 2.1  (0.7) 2.1  (0.8) 2.2  (0.8) 2.1  (0.8)
[1]
Measure Description: Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 11:Anxiety (Somatic)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.4  (0.8) 1.5  (0.8) 1.6  (0.9) 1.6  (0.9) 1.5  (0.9)
[1]
Measure Description: Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 13:Somatic Symptoms/General   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.6  (0.6) 1.7  (0.5) 1.7  (0.5) 1.7  (0.6) 1.7  (0.5)
[1]
Measure Description: Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 14:Genital Symptoms   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.3  (0.8) 1.2  (0.9) 1.3  (0.8) 1.1  (0.9) 1.2  (0.8)
[1]
Measure Description: Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 15:Hypochondriasis   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.7  (0.8) 0.7  (0.8) 1.0  (0.9) 1.1  (0.9) 0.9  (0.9)
[1]
Measure Description: Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 16:Loss of Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.3  (0.6) 0.2  (0.5) 0.3  (0.6) 0.4  (0.7) 0.3  (0.6)
[1]
Measure Description: Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 17:Insight   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.2  (0.4) 0.2  (0.4) 0.1  (0.2) 0.0  (0.2) 0.1  (0.4)
[1]
Measure Description: Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 18A:Diurnal Variation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.8  (0.8) 0.9  (0.9) 1.0  (0.9) 1.0  (0.9) 0.9  (0.9)
[1]
Measure Description: Measures whether symptoms are worse in morning or evening on a scale of 0 (no variation), 1 (worse in morning), or 2 (worse in evening).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 1:Depressed Mood   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
3.0  (0.6) 2.9  (0.6) 2.9  (0.6) 2.9  (0.5) 2.9  (0.6)
[1]
Measure Description: Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 20:Paranoid Symptoms   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.2  (0.5) 0.2  (0.5) 0.2  (0.5) 0.2  (0.4) 0.2  (0.5)
[1]
Measure Description: Measures paranoid symptoms on a scale of 0 (none) to 3 (delusions of reference and persecution).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 22B:Helplessness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.4  (1.0) 1.5  (1.0) 1.5  (1.0) 1.7  (1.0) 1.5  (1.0)
[1]
Measure Description: Measures feelings of helplessness on a scale of 0 (absent) to 4 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 23B:Hopelessness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.3  (0.8) 1.3  (0.9) 1.3  (0.8) 1.3  (0.9) 1.3  (0.8)
[1]
Measure Description: Measures feelings of hopelessness on a scale of 0 (absent) to 3 (expresses feelings of discouragement, despair, and/or pessimism about the future which cannot be dispelled).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 24B:Worthlessness   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.5  (1.0) 1.5  (1.0) 1.6  (1.1) 1.6  (1.1) 1.5  (1.0)
[1]
Measure Description: Measures feelings of worthlessness on a scale of 0 (absent) to 4 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 2:Feelings of Guilt   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.8  (0.7) 2.0  (0.7) 1.8  (0.6) 1.7  (0.8) 1.8  (0.7)
[1]
Measure Description: Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 3:Suicide   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.6  (0.7) 0.7  (0.7) 0.6  (0.8) 0.6  (0.8) 0.6  (0.8)
[1]
Measure Description: Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 4:Insomnia Early   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.5  (0.8) 1.4  (0.8) 1.4  (0.8) 1.4  (0.8) 1.4  (0.8)
[1]
Measure Description: Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 5:Insomnia Middle   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.5  (0.7) 1.5  (0.6) 1.4  (0.8) 1.5  (0.7) 1.5  (0.7)
[1]
Measure Description: Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 6:Insomnia Late   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.2  (0.8) 1.3  (0.8) 1.1  (0.8) 1.1  (0.8) 1.2  (0.8)
[1]
Measure Description: Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 7:Work and Activities   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
2.9  (0.5) 2.8  (0.6) 2.8  (0.5) 2.8  (0.5) 2.8  (0.5)
[1]
Measure Description: Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 8:Retardation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
1.1  (0.7) 1.0  (0.7) 1.1  (0.8) 1.1  (0.9) 1.1  (0.8)
[1]
Measure Description: Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) - Item 9:Agitation   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.9  (0.9) 0.9  (0.8) 0.9  (0.9) 1.0  (0.9) 0.9  (0.9)
[1]
Measure Description: Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Anxiety/Somatization Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
6.8  (2.1) 6.9  (1.9) 7.1  (2.3) 7.3  (2.4) 7.0  (2.2)
[1]
Measure Description: The Anxiety/Somatization subscale (items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Bech Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
12.6  (2.0) 12.5  (1.7) 12.4  (1.9) 12.3  (2.2) 12.5  (2.0)
[1]
Measure Description: The Bech subscale (Items 1,2,7,8,10,13) evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Maier Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
11.8  (2.2) 11.7  (1.9) 11.6  (2.2) 11.6  (2.4) 11.7  (2.2)
[1]
Measure Description: The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Retardation Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
8.2  (1.6) 8.0  (1.6) 8.0  (1.6) 7.9  (1.6) 8.1  (1.6)
[1]
Measure Description: The Retardation subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Sleep Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
4.2  (1.6) 4.3  (1.5) 3.9  (1.7) 4.0  (1.5) 4.1  (1.6)
[1]
Measure Description: The Sleep subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
Evaluation - 24-Item Hamilton Depression Rating Scale (HAMD-24) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
28.6  (6.0) 28.6  (5.5) 28.7  (6.2) 29.0  (6.7) 28.7  (6.1)
[1]
Measure Description: The 24-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76.
Evaluation - 24-Item Hamilton Depression Rating Scale - Item 12:Somatic Symptoms/Gastrointestinal   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.7  (0.7) 0.6  (0.7) 0.6  (0.7) 0.7  (0.7) 0.7  (0.7)
[1]
Measure Description: Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).
Evaluation - 24-Item Hamilton Depression Rating Scale - Item 18B:Diurnal Variation-Severity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.8  (0.8) 0.9  (0.9) 0.9  (0.8) 1.0  (0.9) 0.9  (0.8)
[1]
Measure Description: Measures the severity of the diurnal variation on a scale of 0 (none) to 2 (severe).
Evaluation - 24-Item Hamilton Depression Rating Scale - Item 19: Depersonalization and Derealization   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.2  (0.6) 0.3  (0.6) 0.2  (0.5) 0.2  (0.5) 0.2  (0.6)
[1]
Measure Description: Measures feelings of unreality on a scale of 0 (absent) to 4 (incapacitating).
Evaluation - 24-Item Hamilton Depression Rating Scale - Item 21:Obsessional and Compulsive Symptoms   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
0.1  (0.4) 0.1  (0.4) 0.1  (0.4) 0.1  (0.4) 0.1  (0.4)
[1]
Measure Description: Measures obsessional and compulsive symptoms on a scale of 0 (absent) to 2 (severe).
Evaluation - Clinical Global Impressions of Severity Scale (CGI-S) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
4.6  (0.6) 4.5  (0.6) 4.7  (0.7) 4.7  (0.7) 4.6  (0.7)
[1]
Measure Description: Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Evaluation - Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
28.4  (6.0) 26.8  (6.1) 28.6  (6.1) 28.6  (5.4) 28.2  (6.0)
[1]
Measure Description: A 7-item patitent-rated questionnaire pertaining to a patient's cognitive and physical well-being. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 questions is scored on a 6-point scale ranging fom 1 (greater than normal) to 6 (totally absent). Total score ranges from 7 to 42.
Evaluation - Pain Numerical Rating Scale (NRS) Score Item 1   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
4.3  (2.8) 4.1  (2.7) 4.5  (3.1) 4.5  (2.8) 4.4  (2.9)
[1]
Measure Description: Item 1=Average musculoskeletal pain severity. Participants are asked to rate their average pain over the last week as measured by an 11-point Likert scale. A score of 0 reflects "no pain" and a score of 10 reflects "worst possible pain".
Evaluation - Pain Numerical Rating Scale (NRS) Score Item 7   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
4.7  (3.0) 4.5  (3.1) 4.7  (3.2) 4.9  (3.2) 4.7  (3.1)
[1]
Measure Description: Item 7=How much they have been bothered by pain over the last week, as measured by an 11-point Likert scale. A score of 0 reflects "not bothered at all" and a score of 10 reflects "extremely bothered".
Evaluation - Sheehan Disability Scale (SDS) Item 1   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
5.5  (2.8) 5.4  (2.7) 5.6  (2.7) 5.3  (2.8) 5.5  (2.7)
[1]
Measure Description: The SDS is completed by the patient and Item 1 is used to assess the effect of the patient's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the patient's work/school life.
Evaluation - Sheehan Disability Scale (SDS) Item 2   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
6.6  (2.4) 6.2  (2.8) 6.4  (2.8) 5.9  (2.5) 6.3  (2.6)
[1]
Measure Description: The SDS is completed by the patient and Item 2 is used to assess the effect of the patient's symptoms on their social life/leisure acitivities. Scores range from 0 to 10 with higher values indicating greater disruption in the patient's social life.
Evaluation - Sheehan Disability Scale (SDS) Item 3   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
6.5  (2.5) 6.0  (2.6) 6.2  (2.6) 6.0  (2.5) 6.2  (2.6)
[1]
Measure Description: The SDS is completed by the patient and Item 3 is used to assess the effect of the patient's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the patient's family life/home responsibilities.
Evaluation - Sheehan Disability Scale (SDS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
19.0  (6.5) 17.8  (7.3) 18.4  (7.1) 17.5  (7.0) 18.3  (6.9)
[1]
Measure Description: The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life.
Evaluation - Social Adaptation Self-Evaluation Scale (SASS) Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
27.2  (7.3) 29.1  (8.4) 27.6  (8.2) 29.3  (8.2) 28.0  (8.0)
[1]
Measure Description: A 21-item self-rated scale that evaluates patient social motivation and behavior in depression. Each of the 21 items is scored from 0 (minimal social adjustment) to 3 (maximal social adjustment). Total score ranges from 0 to 60.
History - Age at First Episode  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
30.0  (13.2) 31.2  (13.7) 30.7  (13.6) 30.0  (12.6) 30.4  (13.3)
History - How Long was Last Major Depressive Disorder (MDD) Episode  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
4.7  (6.3) 5.0  (7.4) 5.2  (6.9) 6.5  (14.5) 5.2  (8.6)
History - Interval Between Start of Current and Remission of Last MDD Episode  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
13.2  (20.1) 12.5  (24.3) 13.1  (22.1) 13.1  (22.2) 13.0  (21.8)
History - Number of Previous Episodes  
Mean (Standard Deviation)
Unit of measure:  Number of previous episodes
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
4.0  (4.8) 3.8  (4.3) 4.9  (5.4) 5.2  (5.4) 4.5  (5.1)
History - Time Since First Episode Date  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
12.3  (11.6) 12.5  (11.6) 14.0  (11.5) 14.0  (12.0) 13.2  (11.7)
History - Time Since Most Recent Episode  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 257 participants 127 participants 261 participants 131 participants 776 participants
44.0  (60.2) 48.8  (69.5) 51.4  (103.3) 59.2  (111.2) 49.8  (87.3)
1.Primary Outcome
Title Change From Baseline to 8 Weeks in 24-Item Hamilton Depression Rating Scale (HAMD-24) Item 7 (Work and Activities)
Hide Description Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
Time Frame baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 214 102 220 110
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.32  (0.07) -1.07  (0.11) -1.37  (0.07) -0.93  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments Repeated Measures Analysis for Group A change from baseline to 8 week endpoint.
Method Mixed Models Analysis
Comments Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Repeated Measures Analysis for Group B change from baseline to 8 week endpoint.
Method Mixed Models Analysis
Comments Model=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
2.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in the 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score and HAMD-24 Subscales (8 Week Endpoint for Maier Subscale)
Hide Description The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Please see baseline demographics for subscale total scores.
Time Frame Baseline, 8 weeks, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 214 102 220 110
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score 12 Week Change (n=194,n=59,n=195,n=64) -12.64  (0.50) -10.33  (0.79) -12.11  (0.47) -8.48  (0.75)
Maier 8 Week Change (n=214,n=102,n=220,n=110) -6.11  (0.27) -4.69  (0.38) -6.13  (0.24) -4.45  (0.33)
Anxiety 12 Week Change (n=194,n=59,n=195,n=64) -3.52  (0.16) -3.12  (0.27) -3.52  (0.17) -2.44  (0.27)
Bech 12 Week Change (n=194,n=59,n=195,n=64) -7.38  (0.29) -6.17  (0.47) -6.98  (0.27) -4.70  (0.43)
Retardation 12 Week Change (n=194,n=59,n=195,n=64) -4.72  (0.19) -4.06  (0.32) -4.49  (0.19) -3.05  (0.31)
Sleep 12 Week Change (n=194,n=59,n=195,n=64) -2.08  (0.13) -1.72  (0.22) -1.91  (0.12) -1.48  (0.20)
Total Score 9 Month Change (n=29,n=9,n=33,n=10) -14.38  (1.02) -13.38  (1.86) -9.56  (1.26) -5.92  (2.32)
Anxiety 9 Month Change (n=29,n=9,n=33,n=10) -4.09  (0.30) -3.88  (0.56) -3.44  (0.35) -2.77  (0.65)
Bech 9 Month Change (n=29,n=9,n=33,n=10) -8.56  (0.58) -8.02  (1.04) -5.80  (0.70) -4.35  (1.30)
Retardation 9 Month Change (n=29,n=9,n=33,n=10) -5.35  (0.40) -5.83  (0.72) -3.68  (0.44) -2.52  (0.81)
Sleep 9 Month Change (n=29,n=9,n=33,n=10) -2.77  (0.23) -2.56  (0.40) -2.55  (0.26) -1.95  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Total Score 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Maier 8 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Anxiety/Somatization 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Bech 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for Retardation 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.149
Comments P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.062
Comments P-value for Sleep 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.629
Comments P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments P-value for Total Score 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.595
Comments P-value for Maier 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.736
Comments P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.368
Comments P-value for Anxiety/Somatization 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.660
Comments P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.334
Comments P-value for Bech 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments P-value for Retardation 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.646
Comments P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.275
Comments P-value for Sleep 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Total Score
Hide Description [Not Specified]
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 193 57 194 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -16.24  (0.62) -13.24  (1.01) -15.60  (0.61) -10.94  (0.96)
9 Month Change (n=29, n=8, n=32, n=10) -17.05  (1.15) -15.22  (2.14) -13.49  (1.45) -9.12  (2.64)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value for 12 Week Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline)
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.167
Comments P-value for 9 Month Change. Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in the HAMD-24 Item 1:Depressed Mood
Hide Description Measures depressed mood on a scale of 0 (absent) to 4 (very depressed).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -1.86  (0.07) -1.52  (0.12) -1.78  (0.07) -1.15  (0.12)
9 Month Change (n=29, n=9, n=33, n=10) -1.44  (0.20) -1.26  (0.34) -1.98  (0.19) -1.65  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.653
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.417
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 2:Feelings of Guilt
Hide Description Measures feelings of guilt on a scale of 0 (absent) to 4 (very guilty).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -1.19  (0.06) -1.06  (0.09) -1.15  (0.05) -0.89  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -1.32  (0.10) -1.21  (0.17) -1.37  (0.06) -1.16  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.204
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change(Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 3:Suicide
Hide Description Measures thoughts of suicide on a scale of 0 (absent) to 4 (attempts suicide).
Time Frame Baseline, 12 weeks, 9 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.46  (0.04) -0.30  (0.06) -0.40  (0.04) -0.29  (0.06)
9 Month Change (n=29, n= 9, n=33, n=10) -1.32  (0.10) -1.21  (0.17) -1.37  (0.06) -1.16  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.100
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 4:Insomnia Early
Hide Description Measures early insomnia on a scale of 0 (no difficulty falling asleep) to 2 (complains of nightly difficulty falling asleep).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.72  (0.06) -0.61  (0.10) -0.68  (0.06) -0.46  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -0.85  (0.13) -0.77  (0.23) -0.71  (0.13) -0.86  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.332
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.775
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.588
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 5:Insomnia Middle
Hide Description Measures middle insomnia on a scale of 0 (no difficulty) to 2 (waking during the night).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.69  (0.05) -0.74  (0.09) -0.66  (0.06) -0.59  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -0.99  (0.11) -0.92  (0.19) -0.99  (0.09) -0.67  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.787
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.086
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 6:Insomnia Late
Hide Description Measures late insomnia on a scale of 0 (no difficulty) to 2 (unable to fall asleep again if gets out of bed).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.66  (0.05) -0.49  (0.09) -0.57  (0.05) -0.45  (0.08)
9 Month Change (n=29, n=9, n=33, n=10) -0.94  (0.05) -0.87  (0.08) -0.78  (0.10) -0.52  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.223
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.473
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.233
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline to 9 Month Endpoint in HAMD-24 - Item 7:Work and Activities
Hide Description Item 7 of the HAMD-24 assesses loss of interest or pleasure in work and activities and is an essential symptom in MDD. Scores range from 0 (no difficulty/no loss) to 4 (difficulty/loss).
Time Frame Baseline, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 29 9 33 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.43  (0.10) -2.55  (0.19) -1.66  (0.13) -1.50  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.577
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 8:Retardation
Hide Description Measures slowness of thought and speech; impaired ability to concentrate; decreased motor activity on a scale of 0 (normal speech and thought) to 4 (complete stupor).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.72  (0.04) -0.69  (0.07) -0.66  (0.04) -0.51  (0.07)
9 Month Change (n=29, n=9, n=33, n=10) -0.89  (0.05) -0.90  (0.09) -1.66  (0.13) -1.50  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.670
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.930
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 9:Agitation
Hide Description Measures agitation on a scale of 0 (none) to 4 (hand-wringing, nail-biting)
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.47  (0.04) -0.48  (0.07) -0.44  (0.05) -0.41  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -0.53  (0.07) -0.61  (0.12) -0.57  (0.11) -0.78  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.896
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.796
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 10:Anxiety (Psychic)
Hide Description Measures anxiety on a scale of 0 (no difficulty) to 4 (fears expressed)
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -1.15  (0.06) -0.90  (0.10) -1.15  (0.06) -0.81  (0.10)
9 Month Change (n=29, n=9, n=33, n=10) -1.23  (0.12) -1.13  (0.20) -1.41  (0.12) -1.70  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.253
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 11:Anxiety (Somatic)
Hide Description Measures physiological concomitants of anxiety on a scale of 0 (absent) to 4 (incapacitating).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.61  (0.05) -0.65  (0.09) -0.68  (0.06) -0.57  (0.10)
9 Month Change (n=29, n=9, n=33, n=10) -0.98  (0.11) -0.94  (0.19) -1.20  (0.08) -1.18  (0.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.913
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 12:Somatic Symptoms/Gastrointestinal
Hide Description Measures gastrointestical somatic symptoms on a scale of 0 (none) to 2 (difficulty eating, requires medication for symptoms).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.44  (0.03) -0.52  (0.06) -0.40  (0.03) -0.32  (0.05)
9 Month Change (n=29, n=9, n=33, n=10) -0.98  (0.11) -0.94  (0.19) -0.46  (0.05) -0.47  (0.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.216
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.853
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.908
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 13:Somatic Symptoms/General
Hide Description Measures general somatic symptoms on a scale of 0 (none) to 2 (any clear-cut symptoms).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.91  (0.05) -0.88  (0.09) -0.75  (0.05) -0.49  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -1.36  (0.11) -1.18  (0.20) -0.94  (0.13) -0.83  (0.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.789
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.414
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.717
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 14:Genital Symptoms
Hide Description Measures genital symptoms (loss of libido, menstrual disturbances) on a scale of 0 (absent) to 2 (severe).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.57  (0.05) -0.54  (0.09) -0.55  (0.06) -0.40  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -0.89  (0.13) -0.77  (0.22) -0.68  (0.08) -0.30  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.637
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 15:Hypochondriasis
Hide Description Measures hypochondriasis on a scale of 0 (not present) to 4 (hypochondriacal delusions).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.36  (0.04) -0.41  (0.06) -0.52  (0.05) -0.41  (0.09)
9 Month Change (n=29, n=9, n=33, n=10) -0.44  (82.99) -0.53  (144.40) -0.61  (0.09) -0.41  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.256
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 16:Loss of Weight
Hide Description Measures weight loss since last visit on a scale of 0 (no weight loss) to 2 (definite weight loss caused by present illness).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.21  (0.02) -0.20  (0.04) -0.25  (0.02) -0.24  (0.04)
9 Month Change (n=29, n=9, n=33, n=10) -0.44  (82.99) -0.53  (144.40) -0.61  (0.09) -0.41  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.741
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.722
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to 12 Week and 9 Month Endpoints in HAMD-24 - Item 17:Insight
Hide Description Measures insight on a scale of 0 (acknowledges being depressed and ill) to 2 (denies being ill at all).
Time Frame Baseline, 12 weeks, 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with non-missing data at baseline and post-baseline visit.
Arm/Group Title Group A - Duloxetine Group A - Placebo Group B - Duloxetine Group B - Placebo
Hide Arm/Group Description:
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
Overall Number of Participants Analyzed 194 59 195 64
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
12 Week Change -0.08  (0.01) -0.07  (0.02) -0.01  (0.01) -0.01  (0.02)
9 Month Change (n=29, n=9, n=33, n=10) -0.44  (82.99) -0.53  (144.40) -0.61  (0.09) -0.41  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.949
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 12 Week Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group A - Duloxetine, Group A - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.000
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group B - Duloxetine, Group B - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.268
Comments Model: Change from baseline=Baseline, Pooled Investigator, Visit, Treatment, Treatment*Visit and Baseline*Visit. P-value for 9 Month Change (Change=Endpoint minus baseline).
Method Mixed Models Analysis
Comments [Not Specified]
21.Secondary Outcome