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A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression (TRY FIRST)

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ClinicalTrials.gov Identifier: NCT00666757
Recruitment Status : Completed
First Posted : April 25, 2008
Results First Posted : June 15, 2010
Last Update Posted : June 15, 2010
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Depression
Interventions Drug: duloxetine
Drug: fluoxetine
Drug: citalopram
Drug: paroxetine
Drug: sertraline
Enrollment 750
Recruitment Details The United States study started in May 2008 and completed in March 2009. A total of 72 sites participated (65 Psychiatric, 5 Family Practice, and 2 Internal Medicine specialties).
Pre-assignment Details  
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description 30-120 milligrams (mgs) orally daily for 12 weeks all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Period Title: Overall Study
Started 372 378
Completed 272 281
Not Completed 100 97
Reason Not Completed
Lost to Follow-up             39             35
Protocol Violation             23             24
Adverse Event             22             12
Withdrawal by Subject             13             17
Lack of Efficacy             3             6
Physician Decision             0             2
Sponsor decision             0             1
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI) Total
Hide Arm/Group Description 30-120 milligrams (mgs) orally daily for 12 weeks all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 372 378 750
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 372 participants 378 participants 750 participants
44.3  (13.01) 43.8  (13.05) 44.1  (13.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 372 participants 378 participants 750 participants
Female
237
  63.7%
259
  68.5%
496
  66.1%
Male
135
  36.3%
119
  31.5%
254
  33.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 372 participants 378 participants 750 participants
African Descent 76 68 144
Caucasian 231 241 472
East/Southeast Asian 2 7 9
Hispanic 59 52 111
Western Asian 1 2 3
Other 3 7 10
Missing 0 1 1
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 372 participants 378 participants 750 participants
372 378 750
[1]
Measure Description: United States study
History, Met Diagnosis of Major Mood Disorder (MDD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 372 participants 378 participants 750 participants
372 378 750
17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
7.45  (2.22) 7.42  (2.25) 7.43  (2.23)
[1]
Measure Description: HAMD-17 Anxiety/Somatization subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe).
17-Item Hamilton Depression Rating Scale (HAMD-17) Bech Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
12.97  (2.13) 13.13  (1.95) 13.05  (2.04)
[1]
Measure Description: HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).
17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
12.47  (2.33) 12.48  (2.22) 12.47  (2.27)
[1]
Measure Description: HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation Subscale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
8.36  (1.55) 8.53  (1.54) 8.45  (1.55)
[1]
Measure Description: The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).
17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Subscale Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
4.73  (1.35) 4.77  (1.33) 4.75  (1.34)
[1]
Measure Description: The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
25.03  (4.44) 25.03  (4.24) 25.03  (4.34)
[1]
Measure Description: The HAMD-17 Total Score is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).
Brief Pain Inventory (BPI) Average 24-Hour Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
2.64  (2.74) 2.98  (2.79) 2.81  (2.77)
[1]
Measure Description: The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine).
History, Age at First Episode   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 372 participants 378 participants 750 participants
31.53  (14.39) 30.42  (14.30) 30.97  (14.34)
[1]
Measure Description: Age when first MDD episode occurred
History, Number of Previous MDD Episodes   [1] 
Mean (Standard Deviation)
Unit of measure:  Episodes
Number Analyzed 372 participants 378 participants 750 participants
6.74  (15.32) 5.09  (11.08) 5.91  (13.37)
[1]
Measure Description: Number of previous MDD episodes
History, Time Since Most Recent MDD Episode   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 372 participants 378 participants 750 participants
11.76  (19.06) 11.92  (30.69) 11.84  (25.57)
[1]
Measure Description: Number of months since most recent MDD episode
Quick Inventory of Depressive Symptomatology (QIDS-SR) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
21.64  (1.71) 21.70  (1.70) 21.67  (1.701)
[1]
Measure Description: The QIDS-SR Total Score is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe) depression.
Sheehan Disability Scale (SDS) Global Functional Impairment Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
22.70  (5.52) 22.72  (6.05) 22.71  (5.79)
[1]
Measure Description: The SDS Global Functional Impairment Score is a total score that is calculated by summing the SDS Item 1, 2, and 3; the score ranges from 0 (unimpaired) to 30 (highly impaired).
Sheehan Disability Scale (SDS) Item 1: Symptoms Disrupted Work/School   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
7.00  (2.40) 7.09  (2.45) 7.05  (2.42)
[1]
Measure Description: The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.
Sheehan Disability Scale (SDS) Item 2: Symptoms Disrupted Social Life/Leisure Activities   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
7.81  (1.97) 7.82  (2.13) 7.82  (2.05)
[1]
Measure Description: The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Sheehan Disability Scale (SDS) Item 3: Symptoms Disrupted Family Life/Home Responsibilities   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
7.67  (2.02) 7.68  (2.28) 7.67  (2.15)
[1]
Measure Description: The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms (kg)
Number Analyzed 372 participants 378 participants 750 participants
86.62  (22.37) 86.23  (23.97) 86.42  (23.18)
World Health Organization Health and Work Performance Questionnaire (HPQ), Absolute Absenteeism   [1] 
Mean (Standard Deviation)
Unit of measure:  Hours lost per week
Number Analyzed 372 participants 378 participants 750 participants
28.64  (59.28) 33.29  (72.90) 31.00  (66.48)
[1]
Measure Description: The HPQ was used to assess the total hours of missed work (absenteeism) per week. The calculation for absolute absenteeism is actual hours worked minus expected hours equals number of missed work days.
World Health Organization Health and Work Performance Questionnaire (HPQ), Absolute Presenteeism   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 372 participants 378 participants 750 participants
48.85  (22.47) 50.63  (23.86) 49.74  (23.16)
[1]
Measure Description: The HPQ was used to assess the participant's performance at work. Participants rated their overall performance on the days worked in the last week on a scale of 0 (worst performance) to 10 (top performance). Values were then multiplied by 10 to create a percentage scale between 0 and 100 percent. Absolute presenteeism equals the difference between the "score for self" and "score for average worker in same job".
1.Primary Outcome
Title Probability of Remission [16-item Quick Inventory of Depressive Symptomatology (QIDS-SR) Score Less Than or Equal to 5 at 12-Week Endpoint]
Hide Description Visitwise probability of participants per treatment meeting remission criteria (QIDS-SR total score [TS]</=5 at week 12 endpoint) were estimated using a pseudolikelihood-based mixed-models repeated measures analysis for a categorical outcome, model included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit & continuous, fixed covariate of baseline QIDS-SR TS, and random effect of participant. Primary analysis contrasted remission probability at week 12 endpoint between treatment groups.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 273 284
Least Squares Mean (Standard Error)
Unit of Measure: Probability of remission
0.36  (0.03) 0.32  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the remission rates at 12 week endpoint between treatment groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in QIDS-SR Total Score at 12-Week Endpoint (Mood Measure)
Hide Description The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 273 284
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-13.4  (0.36) -12.6  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Probability of Remission [17-item Hamilton Depression Rating Scale (HAMD-17) (Mood Measure) Less Than or Equal to 7 at 12-Week Endpoint]
Hide Description Visitwise percentages of participants meeting remission criteria HAMD-17 total score [TS] </=7 at week 12 endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group (duloxetine vs. SSRIs), visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be contrast of remission rates at week 12 endpoint between treatment groups, & represents estimated remission rates for each treatment group had all participants completed 12 weeks of therapy.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371 and Week 12: Duloxetine N=272, SSRI N=283
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 272 283
Least Squares Mean (Standard Error)
Unit of Measure: Probability of remission
0.53  (0.03) 0.44  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). Repeated Measures Analysis. The analysis will contrast the remission remission rates at 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Probability of Response [QIDS-SR Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
Hide Description Visitwise percentages of participants meeting response criteria (50% reduction from baseline QIDS-SR total score at 12-week endpoint) were estimated using a categorical, pseudolikelihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline QIDS-SR. The primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, and represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
Time Frame Baseline, 12-Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 273 284
Least Squares Mean (Standard Error)
Unit of Measure: Probability of response
0.71  (0.03) 0.64  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Probability of Response [HAMD-17 Total Score (Mood Measure) Greater Than Or Equal To 50 Percent Reduction From Baseline To 12 Week Endpoint]
Hide Description Visitwise percentages of participants meeting response criteria 50% reduction from baseline in HAMD-17 total score at 12-Week endpoint) were estimated using a categorical, pseudolike-lihood-based repeated measures approach, & included fixed, categorical effects of treatment group, visit, treatment group-by-visit interaction, & continuous, fixed covariate of baseline HAMD-17 TS. Primary analysis will be the contrast of response rates at week 12 endpoint between treatment groups, & represents estimated response rates for each treatment group had all participants completed 12 weeks of therapy.
Time Frame Baseline, 12-Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and Week 12: Duloxetine N=272, SSRI N=283
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 272 283
Least Squares Mean (Standard Error)
Unit of Measure: Probability of response
0.73  (0.03) 0.61  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Categorical, pseudo-likelihood-based repeated measures approach (MMRM-CAT). The analysis will contrast the response rates at 12-week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in HAMD-17 Total Score at 12-Week Endpoint (Mood Measure)
Hide Description The HAMD-17 is a rater-administered assessment of depression severity and improvement, with total score ranges from 0 (not at all depressed) to 52 (most severely depressed).
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=365, SSRI N=371; and; and Week 12: Duloxetine N=272, SSRI N=283
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 272 283
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-17.03  (0.43) -15.3  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score at 12-Week Endpoint (Mood Measure)
Hide Description HAMD-17 subscale consists of items 10, 11, 12, 13, 15, and 17 evaluates agitation, and severity of psychic and somatic manifestations of anxiety. Total subscale scores range from 0 (normal) to 18 (severe). Mean change from baseline to endpoint.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 284
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.89  (0.16) -4.24  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in HAMD-17 Maier Subscale Score at 12-Week Endpoint (Mood Measure)
Hide Description HAMD-17 Maier Subscale consists of Items 1, 2, 7, 8, 9, 10 and represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe).
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 284
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.01  (0.23) -8.16  (0.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in HAMD-17 Bech Subscale Score at 12-Week Endpoint (Mood Measure)
Hide Description HAMD-17 Bech subscale consists of items 1, 2, 7, 8, 10, and 13 used to evaluate core symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274; SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 284
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-9.21  (0.24) -8.40  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis.Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in HAMD-17 Retardation Subscale Score at 12-Week Endpoint (Mood Measure)
Hide Description The HAMD-17 Retardation subscale consists of Items 1, 7, 8, 14 and evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe).
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=371; and Week 12: Duloxetine N=273, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 273 284
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.99  (0.16) -5.49  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in HAMD-17 Sleep Subscale Score at 12-Week Endpoint (Mood Measure)
Hide Description The HAMD-17 Sleep Subscale consists of Items 4, 5, 6 and evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 285
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.77  (0.12) -2.58  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) Average 24-hour Pain Score, in Particpants With a Baseline BPI Average 24-hour Pain Score of 3 or Greater, at 12-Week Endpoint (Pain Measure)
Hide Description The BPI is a self-reported scale measuring pain severity and pain-specific interference on function on a scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint, in those participants who had a BPI average 24-hour pain score of 3 or greater at baseline.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=211, SSRI N=233; and Week 12: Duloxetine N=156, N=166
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 156 166
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.95  (0.21) -2.39  (0.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Only those patients who had at least moderate pain at baseline (defined as baseline BPI Average 24-Hour Pain Score greater than or equal to 3). Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in BPI Average 24 Hour Pain Score at 12-Week Endpoint (Pain Measure)
Hide Description The BPI is a self-reported scale measuring pain severity and pain-specific interference on function, with scores ranging from 0 (does not interfere) to 10 (completely interferes). The BPI average 24-hour pain measure was used to derive the overall mean change from baseline to endpoint.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=346, SSRI N=348; and Week 12: Duloxetine N=249, SSRI N=257
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 249 257
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.83  (0.15) -1.43  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score at 12-Week Endpoint (Functional Outcome Measure)
Hide Description The SDS is a participant-rated anchored visual analog scale to assess disability across the three domains of work/school, social life, and family life, with each item scored from 0 (not at all) to 10 (very severely), with a summarization of the 3 items to evaluate global functioning. The Global Functional Impairment Score is a total score score that ranges from 0 (unimpaired) to 30 (highly impaired), and was used to derived the mean change from baseline to endpoint.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 270 283
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-13.56  (0.53) -11.53  (0.52)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at 12-Week endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in SDS Work/School Item Score at 12-Week Endpoint (Functional Outcome Measure)
Hide Description The SDS is completed by the participant and Item 1 is used to assess the effect of the participant's symptoms on their work/school schedule. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's work/school life.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=260,SSRI N=267; and Week 12: Duloxetine N=182, SSRI N=192
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 182 192
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.52  (0.22) -3.85  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in Sheehan Disability Scale (SDS) Family/Home Item Score at Week-12 Endpoint (Functional Outcome Measure)
Hide Description The SDS is completed by the participant and Item 3 is used to assess the effect of the participant's symptoms on their family life/home responsibilities. Scores range from 0 to 10 with higher values indicating greater disruption in the participant's family life/home responsibilities.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=363, SSRI N=370; and Week 12: Duloxetine N=271, SSRI N=283
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 271 283
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.51  (0.19) -3.94  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in SDS Social Item Score at 12-Week Endpoint (Functional Outcome Measure)
Hide Description The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=362, SSRI N=370; and Week 12: Duloxetine N=270, SSRI N=283
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 270 283
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-4.69  (0.18) -4.04  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at Week-12 Endpoint
Hide Description Mean change from baseline to endpoint in systolic blood pressure
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 285
Least Squares Mean (Standard Error)
Unit of Measure: millimeters of mmercury (mmHg)
0.58  (0.69) 0.55  (0.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Week-12 Endpoint
Hide Description Mean change from baseline to endpoint in diastolic blood pressure
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371: and Week 12: Duloxetine N=274, SSRI N=285
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 285
Least Squares Mean (Standard Error)
Unit of Measure: mmHg
-0.14  (0.48) 0.45  (0.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline in Pulse Rate at Week-12 Endpoint
Hide Description Mean change from baseline to endpoint in pulse rate
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=367, SSRI N=371; and Week 12: Duloxetine N=274, SSRI N=285
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 274 285
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
2.74  (0.58) 0.47  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline in Weight at Week-12 Endpoint
Hide Description Mean change from baseline to endpoint in weight
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Data based on number of subjects enrolled at Week 0: Duloxetine N=366, SSRI N=370; and Week 12: Duloxetine N=273, SSRI N=284
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 273 284
Least Squares Mean (Standard Error)
Unit of Measure: kilograms (kg)
-0.32  (0.18) -0.17  (0.18)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Repeated Measures Analysis. Treatment comparisons will include the contrast between treatment groups at endpoint.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
22.Other Pre-specified Outcome
Title Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Presenteeism (WP)Score, at Week-12 Endpoint
Hide Description WP score was calculated by taking midpoint of annual before-tax income reported on HPQ. A multiplier of 1.25 produced estimated direct & indirect (i.e. benefits) income. Annual hours expected to work were calculated from expected daily work hours, multiplied by 236 days. Hourly, indirect income was total direct + indirect income, divided by # of expected annual work hours. Indirect hours lost annually for WP=hours expected to be worked annually times WP percent, times hourly rate=dollars earned, and then subtracted from total direct + indirect income=dollars lost annually due to WP.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Last Observation Carried Forward.
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 130 132
Least Squares Mean (Standard Error)
Unit of Measure: dollars
7250.93  (954.77) 5074.09  (957.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments Between group P-value
Method ANCOVA
Comments [Not Specified]
23.Other Pre-specified Outcome
Title Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Dollars of Income Lost Due to Work Absenteeism Score at Week-12 Endpoint
Hide Description Self-administered assessment used to determine a participant's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Scale ranges from 0 to 100% of work days in past 30 days. Absenteeism and presenteeism were combined into a measure of total lost work performance by adding absenteeism to the value ([100–absenteeism] × [100–presenteeism]). Mean change baseline to endpoint.
Time Frame Baseline, 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Last Observation Carried Forward.
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 134 142
Least Squares Mean (Standard Error)
Unit of Measure: dollars
-3978.98  (1708.92) -1932.46  (1689.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments Between group P-value
Method ANCOVA
Comments [Not Specified]
24.Other Pre-specified Outcome
Title Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Absenteeism at 12-Week Endpoint
Hide Description Self-administered assessment used to determine a subject's work performance in terms of employment status, absenteeism if employed, productivity while at work, usual occupation, and annual income. Tool assesses the potential impact of change in depressive symptoms on work productivity and its associated employer costs. Defined on a 0–100 scale for the percentage of work days the respondent missed in the past 30 days. Absolute absenteeism: actual hours worked minus expected hours equals number of missed work days. Mean change baseline to endpoint is reported.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Last Observation Carried Forward.
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 137 146
Least Squares Mean (Standard Error)
Unit of Measure: hours lost per week
-9.56  (5.14) 0.41  (5.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Transformed absolute score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Between group P-value
Method ANCOVA
Comments [Not Specified]
25.Other Pre-specified Outcome
Title Change From Baseline in World Health Organization Health and Work Performance Questionnaire, Clinical Trials 7-Day Version (HPQ), Presenteeism Score, at Week-12 Endpoint
Hide Description Self-administered assessment used to determine a participant's work performance (employment status, absenteeism if employed, productivity while at work, usual occupation, & annual income). Tool assesses the potential impact of change in depressive symptoms on work productivity & its associated employer costs using a 0–100 scale in which 0 meant doing no work at all on days spent at work and 100 meant performing at the level of a top worker. Absolute presenteeism: difference between "score for self" and "score for average worker in same job". Mean change baseline to endpoint is reported.
Time Frame Baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat. Last Observation Carried Forward.
Arm/Group Title Duloxetine Selective Serotonin Reuptake Inhibitor (SSRI)
Hide Arm/Group Description:
30-120 milligrams (mgs) orally daily for 12 weeks
all comparator SSRIs pooled together: citalopram 20-40 mgs orally daily for 12 weeks; fluoxetine 20-80 mg orally daily for 12 weeks; paroxetine 20-50 mgs orally daily for 12 weeks; and sertraline 50-200 mgs orally daily for 12 weeks
Overall Number of Participants Analyzed 136 139
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
24.56  (2.14) 20.73  (2.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Selective Serotonin Reuptake Inhibitor (SSRI)
Comments Transformed Absolute Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments Between group P-value
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Citalopram Fluoxetine Paroxetine Sertraline
Hide Arm/Group Description 30-120 mg orally daily for 12 weeks 20-40 mg orally daily for 12 weeks 20-80 mg orally daily for 12 weeks 20-50 mg orally daily for 12 weeks 50-200 mg orally daily for 12 weeks
All-Cause Mortality
Duloxetine Citalopram Fluoxetine Paroxetine Sertraline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Citalopram Fluoxetine Paroxetine Sertraline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/372 (1.08%)      2/157 (1.27%)      1/57 (1.75%)      1/45 (2.22%)      2/119 (1.68%)    
Infections and infestations           
Pneumonia  1  0/372 (0.00%)  0 1/157 (0.64%)  1 0/57 (0.00%)  0 0/45 (0.00%)  0 0/119 (0.00%)  0
Injury, poisoning and procedural complications           
Cervical vertebral fracture  1  0/372 (0.00%)  0 0/157 (0.00%)  0 0/57 (0.00%)  0 0/45 (0.00%)  0 1/119 (0.84%)  1
Tibia fracture  1  1/372 (0.27%)  1 0/157 (0.00%)  0 0/57 (0.00%)  0 0/45 (0.00%)  0 0/119 (0.00%)  0
Metabolism and nutrition disorders           
Hyponatraemia  1  0/372 (0.00%)  0 0/157 (0.00%)  0 0/57 (0.00%)  0 1/45 (2.22%)  1 0/119 (0.00%)  0
Nervous system disorders           
Cerebrovascular accident  1  0/372 (0.00%)  0 0/157 (0.00%)  0 1/57 (1.75%)  1 0/45 (0.00%)  0 0/119 (0.00%)  0
Temporal lobe epilepsy  1  1/372 (0.27%)  1 0/157 (0.00%)  0 0/57 (0.00%)  0 0/45 (0.00%)  0 0/119 (0.00%)  0
Psychiatric disorders           
Post-traumatic stress disorder  1  0/372 (0.00%)  0 0/157 (0.00%)  0 0/57 (0.00%)  0 0/45 (0.00%)  0 1/119 (0.84%)  1
Suicidal ideation  1  1/372 (0.27%)  1 0/157 (0.00%)  0 0/57 (0.00%)  0 0/45 (0.00%)  0 0/119 (0.00%)  0
Renal and urinary disorders           
Nephrolithiasis  1  1/372 (0.27%)  1 0/157 (0.00%)  0 0/57 (0.00%)  0 0/45 (0.00%)  0 0/119 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  0/372 (0.00%)  0 1/157 (0.64%)  1 0/57 (0.00%)  0 0/45 (0.00%)  0 0/119 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA(11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine Citalopram Fluoxetine Paroxetine Sertraline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   277/372 (74.46%)      112/157 (71.34%)      47/57 (82.46%)      36/45 (80.00%)      86/119 (72.27%)    
Gastrointestinal disorders           
Constipation  1  33/372 (8.87%)  35 8/157 (5.10%)  8 1/57 (1.75%)  2 2/45 (4.44%)  2 3/119 (2.52%)  3
Diarrhoea  1  36/372 (9.68%)  41 17/157 (10.83%)  18 10/57 (17.54%)  10 3/45 (6.67%)  3 18/119 (15.13%)  20
Dry mouth  1  66/372 (17.74%)  67 16/157 (10.19%)  16 11/57 (19.30%)  11 4/45 (8.89%)  4 13/119 (10.92%)  13
Nausea  1  63/372 (16.94%)  70 17/157 (10.83%)  18 8/57 (14.04%)  9 8/45 (17.78%)  8 15/119 (12.61%)  16
General disorders           
Fatigue  1  27/372 (7.26%)  28 10/157 (6.37%)  10 2/57 (3.51%)  3 8/45 (17.78%)  8 3/119 (2.52%)  3
Infections and infestations           
Nasopharyngitis  1  11/372 (2.96%)  11 5/157 (3.18%)  5 1/57 (1.75%)  2 4/45 (8.89%)  4 5/119 (4.20%)  5
Upper respiratory tract infection  1  10/372 (2.69%)  10 8/157 (5.10%)  8 2/57 (3.51%)  2 1/45 (2.22%)  1 5/119 (4.20%)  5
Metabolism and nutrition disorders           
Decreased appetite  1  18/372 (4.84%)  18 5/157 (3.18%)  5 4/57 (7.02%)  4 0/45 (0.00%)  0 1/119 (0.84%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia  1  5/372 (1.34%)  6 3/157 (1.91%)  5 3/57 (5.26%)  3 2/45 (4.44%)  2 2/119 (1.68%)  2
Back pain  1  10/372 (2.69%)  13 4/157 (2.55%)  4 3/57 (5.26%)  3 1/45 (2.22%)  1 2/119 (1.68%)  2
Nervous system disorders           
Dizziness  1  23/372 (6.18%)  26 4/157 (2.55%)  4 1/57 (1.75%)  1 5/45 (11.11%)  5 7/119 (5.88%)  7
Headache  1  55/372 (14.78%)  62 16/157 (10.19%)  18 8/57 (14.04%)  11 6/45 (13.33%)  6 16/119 (13.45%)  19
Somnolence  1  27/372 (7.26%)  27 11/157 (7.01%)  11 2/57 (3.51%)  2 3/45 (6.67%)  3 3/119 (2.52%)  3
Psychiatric disorders           
Anorgasmia  1  4/372 (1.08%)  4 3/157 (1.91%)  3 1/57 (1.75%)  1 3/45 (6.67%)  3 0/119 (0.00%)  0
Insomnia  1  25/372 (6.72%)  25 3/157 (1.91%)  3 8/57 (14.04%)  9 3/45 (6.67%)  3 4/119 (3.36%)  4
Skin and subcutaneous tissue disorders           
Hyperhidrosis  1  12/372 (3.23%)  13 1/157 (0.64%)  1 3/57 (5.26%)  3 3/45 (6.67%)  3 6/119 (5.04%)  6
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA(11.0)
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00666757     History of Changes
Other Study ID Numbers: 11715
F1J-US-HMFT ( Other Identifier: Eli Lilly and Company )
First Submitted: April 23, 2008
First Posted: April 25, 2008
Results First Submitted: February 16, 2010
Results First Posted: June 15, 2010
Last Update Posted: June 15, 2010