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Trial record 34 of 88 for:    "Neuromuscular Disease" | "Norepinephrine"

A Study for Adult Patients With Fibromyalgia (HMGG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00965081
Recruitment Status : Completed
First Posted : August 25, 2009
Results First Posted : November 3, 2011
Last Update Posted : November 3, 2011
Sponsor:
Information provided by (Responsible Party):
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
Conditions Fibromyalgia, Primary
Fibromyalgia, Secondary
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 308
Recruitment Details  
Pre-assignment Details Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Period Title: Overall Study
Started 155 [1] 153
Completed 121 [2] 110
Not Completed 34 43
Reason Not Completed
Adverse Event             14             9
Lack of Efficacy             2             5
Lost to Follow-up             4             5
Physician Decision             2             0
Protocol Violation             2             5
Sponsor Decision             1             0
Withdrawal by Subject             4             7
Switched to Rescue Arm             5             12
[1]
2 randomized participants had no post-baseline measures and are not included in outcome measures.
[2]
In addition, 16/17 rescue participants completed study on protocol-specified study medication.
Arm/Group Title Duloxetine Placebo Total
Hide Arm/Group Description

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Total of all reporting groups
Overall Number of Baseline Participants 155 153 308
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants 153 participants 308 participants
50.89  (11.90) 50.72  (12.45) 50.80  (12.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
Female
146
  94.2%
147
  96.1%
293
  95.1%
Male
9
   5.8%
6
   3.9%
15
   4.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
American Indian or Alaska Native 13 12 25
Asian 3 0 3
Black or African American 6 5 11
White 133 136 269
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
Argentina 40 38 78
Israel 14 14 28
Mexico 42 42 84
Puerto Rico 3 3 6
United States 56 56 112
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms/meters squared (kg/m2)
Number Analyzed 155 participants 153 participants 308 participants
28.91  (6.00) 29.49  (6.90) 29.20  (6.46)
[1]
Measure Description: BMI is an estimate of body fat based on body weight divided by height squared (kg/m^2).
Brief Pain Inventory (BPI) Average Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
6.50  (1.47) 6.37  (1.67) 6.44  (1.57)
[1]
Measure Description: The BPI-Modified Short Form is a self-reported scale that measures the severity of pain and the interference of pain on function. Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI Average Pain score assesses severity of average pain in the past 24 hours.
Brief Pain Inventory (BPI) Mean Interference Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
5.97  (2.17) 5.78  (2.28) 5.88  (2.23)
[1]
Measure Description: The BPI Mean Interference Score measures mean interference of pain on function in the past 24 hours on 7 items including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life. Scores range from 0 (does not interfere) to 10 (completely interferes).
Fibromyalgia Impact Questionnaire (FIQ) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
51.11  (12.17) 50.44  (13.71) 50.78  (12.94)
[1]
Measure Description: The FIQ measures participant status, progress, and outcomes over the past week. It consists of 20 items; the first 11 items measure physical functioning. Each item is rated on a 4-point scale. Items 12 and 13 measure number of days participant felt well and number of days participant felt unable to work due to fibromyalgia symptoms. Items 14-20 are numerical, 11-point scales rating work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score ranges from 0 to 80. A higher score indicates a more negative impact.
Beck Depression Inventory (BDI) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
15.00  (9.64) 16.84  (11.47) 15.92  (10.61)
[1]
Measure Description: The BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire was used to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
Clinical Global Impression of Severity (CGI-S) for Depression Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
2.30  (1.38) 2.45  (1.45) 2.38  (1.42)
[1]
Measure Description: The CGI-S for depression scale evaluates the severity of depression at the time of assessment. The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The CGI-S for depression scale was administered by a study physician in the presence of the participant or after having been in the presence of the participant. Number of Participants: Duloxetine = 153, Placebo = 151; scales incorrectly administered were omitted from summary.
Patient's Global Impressions of Severity (PGI-S) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
3.74  (1.33) 3.74  (1.47) 3.74  (1.40)
[1]
Measure Description: The PGI-S scale is a participant-rated instrument that measures perceived severity of symptoms. It is a 7-point scale where a score of 1 indicates that the patient is “normal, not at all ill,” a score of 4 indicates that the patient is “moderately ill,” and a score of 7 indicates that the patient is “extremely ill.”
Beck Anxiety Inventory (BAI) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 155 participants 153 participants 308 participants
14.26  (9.35) 15.04  (10.69) 14.65  (10.04)
[1]
Measure Description: The BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety. Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme). This questionnaire was used to rate the severity of anxiety symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms. Number of Participants: Duloxetine = 152, Placebo = 153; scales incorrectly administered were omitted from summary.
Diagnosis of Major Depressive Disorder (MDD)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
Diagnosis of MDD 32 37 69
No diagnosis of MDD 123 116 239
[1]
Measure Description: The Mini International Neuropsychiatric Interview (MINI)was administered to establish if the participant had MDD.
Diagnosis of Generalized Anxiety Disorder (GAD)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants 153 participants 308 participants
Diagnosis of GAD 11 8 19
No diagnosis of GAD 144 145 289
[1]
Measure Description: The MINI was administered to establish if the participant had GAD.
1.Primary Outcome
Title Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
Hide Description BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: all randomized participants. ITT treatment group is group to which participant was randomized regardless of treatment actually received. BOCF method used to impute endpoint value if initial DBT discontinued due to AE. Change from baseline analyses included all those with baseline and ≤1 post-baseline observation.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 153 153
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-2.04  (0.20) -1.70  (0.20)
2.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form
Hide Description BPI-Modified Short Form mean interference score ranges from 0 (does not interfere) to 10 (completely interferes) for pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Treatment group difference in the Least Squares (LS) Means changes from baseline to endpoint is from an analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators and baseline. Last-observation-carried forward (LOCF) endpoint defined as last available post-baseline value obtained during initial double-blind therapy.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per initial group assignments. The LOCF method was used to impute the missing endpoint during initial double-blind therapy.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 153 153
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Worst Pain -2.23  (0.23) -1.98  (0.23)
Least Pain -1.56  (0.20) -1.36  (0.20)
Pain Right Now -2.25  (0.23) -1.90  (0.23)
Pain Interference - General Activity -2.19  (0.24) -1.91  (0.24)
Pain Interference - Mood -2.40  (0.24) -1.82  (0.24)
Pain Interference - Walking ability -2.31  (0.22) -1.74  (0.22)
Pain Interference - Normal Work -2.20  (0.24) -1.77  (0.24)
Pain Interference - Relations with Other People -2.05  (0.23) -1.34  (0.23)
Pain Interference - Sleep -2.06  (0.25) -1.75  (0.25)
Pain Interference - Enjoyment of Life -2.48  (0.24) -1.93  (0.24)
Mean Interference Score -2.28  (0.20) -1.78  (0.20)
3.Secondary Outcome
Title Patient Global Impression - Improvement (PGI-I) at Endpoint
Hide Description The PGI-I scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale: score of 1 is "very much better," 4 is "no change," and 7 is "very much worse." Treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA); model included terms for treatment group, pooled investigators and baseline PGI-Severity (PGI-S).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 153 153
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.97  (0.12) 3.35  (0.12)
4.Secondary Outcome
Title Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint
Hide Description

The CGI-I measures clinician's perception of patient improvement at time of assessment compared with start of treatment. Scores range from 1 (very much improved) to 7 (very much worse).

The treatment group difference in Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline CGI-Severity (CGI-S).

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 152 153
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
3.34  (0.09) 3.51  (0.09)
5.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)
Hide Description The BDI-II is a 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a 4-point scale for each item ranging from 0 to 3 (0 = not present; 3 = present in the extreme). The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method was used to impute the missing endpoint during initial double-blind therapy.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 140 134
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-5.47  (0.60) -3.91  (0.61)
6.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)
Hide Description FIQ is a 20-item self-administered questionnaire that measures fibromyalgia (FM) patient status, progress, and outcomes over the past week. The total score ranges from 0 to 80 with higher scores reflecting a more negative impact of FM. The treatment group difference in the Least Squares (LS) Means change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per randomly assigned groups. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy(DB) due to adverse event; last non-missing observation during initial DB used to impute the missing endpoint for all others.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 153 153
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-14.62  (1.38) -9.75  (1.38)
7.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)
Hide Description

The BAI is a 21-item patient-completed questionnaire designed to assess the characteristics of anxiety. Each item is rated on a 4-point scale (0=not present; 3=present in the extreme). The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.

The treatment group difference in the Least Squares (LS) Means at endpoint is from an analysis of covariance (ANCOVA). The model included terms for treatment group, pooled investigators and baseline.

Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint during initial double-blind therapy.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 138 132
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
-3.76  (0.67) -3.31  (0.68)
8.Secondary Outcome
Title Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)
Hide Description SF-36 has 36 items with 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional, general health; each scored on 0 to 100 scale. Higher scores indicate better status. Mental component summary (MCS) and physical component summary (PCS) based on 8 SF-36 domains. Scales scored using norm-based methods; mean is 50 and standard deviation is 10 in U.S. population. Treatment group difference in Least Squares (LS) Means at endpoint from analysis of covariance. Terms for treatment group, pooled investigators, baseline in model.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT) population: analyses conducted per initial group assignments. The last-observation-carried-forward (LOCF) method used to impute the missing endpoint.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 153 153
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Bodily Pain Transformed (n=141, n=135) 17.06  (1.87) 14.01  (1.89)
General Health Transformed (n=140, n=134) 7.88  (1.47) 6.12  (1.50)
Mental Health Transformed (n=141, n=135) 9.36  (1.56) 5.55  (1.59)
Physical Functioning (n=141, n=135) 9.53  (1.74) 6.34  (1.76)
Role-Emotional (n=141, n=135) 18.88  (3.45) 10.69  (3.50)
Role-Physical (n=141, n=135) 18.55  (3.48) 13.13  (3.52)
Social Functioning (n=141, n=135) 14.05  (1.93) 6.75  (1.95)
Vitality (n=141, n=135) 11.87  (1.73) 7.59  (1.74)
Mental Component (n=140, n=134) 5.56  (0.85) 2.87  (0.87)
Physical Component (n=140, n=134) 4.75  (0.72) 3.91  (0.73)
9.Secondary Outcome
Title Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)
Hide Description

The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors. The number of participants with suicidal behaviors and ideations are provided.

Suicidal behavior: a “yes” answer to any of 5 suicidal behavior questions which include: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.

Suicidal ideation: a “yes” answer to any 1 of 5 suicidal ideation questions which include wish to be dead and 4 different categories of active suicidal ideation.

Time Frame Baseline through 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants having at least 1 post-baseline C-SSRS assessment were included in this analysis.
Arm/Group Title Duloxetine Placebo
Hide Arm/Group Description:

Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks

Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression.

Overall Number of Participants Analyzed 152 153
Measure Type: Number
Unit of Measure: Participants
Wish to be dead 3 3
Non-specific active suicidal thoughts 1 0
Active suicidal ideation with no intent to act 1 0
Active suicidal ideation, some intent, no plan 0 0
Active suicidal ideation with specific plan/intent 0 0
Suicidal behavior - Preparatory acts or behavior 0 0
Suicidal behavior - Aborted attempt 0 0
Suicidal behavior - Interrupted attempt 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Duloxetine 30 mg Duloxetine 60 mg
Hide Arm/Group Description Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks. Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
All-Cause Mortality
Placebo Duloxetine 30 mg Duloxetine 60 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Duloxetine 30 mg Duloxetine 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/153 (0.65%)      0/155 (0.00%)      0/17 (0.00%)    
Gastrointestinal disorders       
Irritable bowel syndrome  1  1/153 (0.65%)  1 0/155 (0.00%)  0 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Placebo Duloxetine 30 mg Duloxetine 60 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   78/153 (50.98%)      100/155 (64.52%)      5/17 (29.41%)    
Cardiac disorders       
Palpitations  1  1/153 (0.65%)  1 3/155 (1.94%)  3 0/17 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  2/153 (1.31%)  2 1/155 (0.65%)  1 0/17 (0.00%)  0
Eye disorders       
Vision blurred  1  1/153 (0.65%)  1 4/155 (2.58%)  4 0/17 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort  1  0/153 (0.00%)  0 2/155 (1.29%)  3 0/17 (0.00%)  0
Abdominal pain  1  4/153 (2.61%)  5 1/155 (0.65%)  1 0/17 (0.00%)  0
Abdominal pain upper  1  1/153 (0.65%)  1 6/155 (3.87%)  6 0/17 (0.00%)  0
Constipation  1  2/153 (1.31%)  2 5/155 (3.23%)  5 0/17 (0.00%)  0
Diarrhoea  1  7/153 (4.58%)  8 7/155 (4.52%)  7 1/17 (5.88%)  1
Dry mouth  1  3/153 (1.96%)  3 13/155 (8.39%)  13 0/17 (0.00%)  0
Gastritis  1  2/153 (1.31%)  2 2/155 (1.29%)  2 0/17 (0.00%)  0
Nausea  1  6/153 (3.92%)  7 33/155 (21.29%)  33 0/17 (0.00%)  0
Vomiting  1  2/153 (1.31%)  2 1/155 (0.65%)  1 0/17 (0.00%)  0
General disorders       
Asthenia  1  1/153 (0.65%)  1 3/155 (1.94%)  3 0/17 (0.00%)  0
Chills  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Fatigue  1  2/153 (1.31%)  2 4/155 (2.58%)  4 0/17 (0.00%)  0
Feeling jittery  1  1/153 (0.65%)  1 3/155 (1.94%)  3 0/17 (0.00%)  0
Infections and infestations       
Cystitis  1  0/153 (0.00%)  0 1/155 (0.65%)  1 1/17 (5.88%)  1
Influenza  1  3/153 (1.96%)  3 3/155 (1.94%)  4 0/17 (0.00%)  0
Nasopharyngitis  1  7/153 (4.58%)  7 4/155 (2.58%)  4 0/17 (0.00%)  0
Pharyngitis  1  5/153 (3.27%)  5 2/155 (1.29%)  2 0/17 (0.00%)  0
Sinusitis  1  3/153 (1.96%)  3 2/155 (1.29%)  2 0/17 (0.00%)  0
Upper respiratory tract infection  1  2/153 (1.31%)  2 3/155 (1.94%)  3 0/17 (0.00%)  0
Urinary tract infection  1  5/153 (3.27%)  5 2/155 (1.29%)  2 1/17 (5.88%)  1
Injury, poisoning and procedural complications       
Fall  1  2/153 (1.31%)  2 0/155 (0.00%)  0 0/17 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  2/153 (1.31%)  2 7/155 (4.52%)  7 0/17 (0.00%)  0
Hypertriglyceridaemia  1  3/153 (1.96%)  3 0/155 (0.00%)  0 0/17 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Back pain  1  3/153 (1.96%)  3 1/155 (0.65%)  1 0/17 (0.00%)  0
Musculoskeletal stiffness  1  2/153 (1.31%)  2 1/155 (0.65%)  1 0/17 (0.00%)  0
Nervous system disorders       
Dizziness  1  6/153 (3.92%)  6 11/155 (7.10%)  12 0/17 (0.00%)  0
Dysgeusia  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Headache  1  15/153 (9.80%)  17 21/155 (13.55%)  21 1/17 (5.88%)  1
Migraine  1  2/153 (1.31%)  3 3/155 (1.94%)  3 0/17 (0.00%)  0
Paraesthesia  1  2/153 (1.31%)  2 4/155 (2.58%)  4 0/17 (0.00%)  0
Sedation  1  1/153 (0.65%)  2 2/155 (1.29%)  2 0/17 (0.00%)  0
Somnolence  1  4/153 (2.61%)  4 9/155 (5.81%)  9 1/17 (5.88%)  1
Tremor  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Psychiatric disorders       
Anxiety  1  3/153 (1.96%)  4 2/155 (1.29%)  2 0/17 (0.00%)  0
Depression  1  3/153 (1.96%)  3 1/155 (0.65%)  1 0/17 (0.00%)  0
Insomnia  1  3/153 (1.96%)  3 8/155 (5.16%)  8 0/17 (0.00%)  0
Renal and urinary disorders       
Urinary incontinence  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/153 (1.31%)  2 1/155 (0.65%)  1 1/17 (5.88%)  1
Oropharyngeal pain  1  3/153 (1.96%)  3 3/155 (1.94%)  3 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hyperhidrosis  1  0/153 (0.00%)  0 4/155 (2.58%)  4 0/17 (0.00%)  0
Pruritus  1  1/153 (0.65%)  2 3/155 (1.94%)  3 0/17 (0.00%)  0
Rash  1  0/153 (0.00%)  0 1/155 (0.65%)  1 1/17 (5.88%)  1
Vascular disorders       
Hot flush  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Hypertension  1  0/153 (0.00%)  0 2/155 (1.29%)  2 0/17 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00965081     History of Changes
Other Study ID Numbers: 12873
F1J-MC-HMGG ( Other Identifier: Eli Lilly and Company )
First Submitted: August 24, 2009
First Posted: August 25, 2009
Results First Submitted: September 28, 2011
Results First Posted: November 3, 2011
Last Update Posted: November 3, 2011