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Trial record 52 of 531 for:    ESCITALOPRAM AND Disorders

A Study of Patients With Major Depressive Disorder and Residual Apathy

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: NCT00985504
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : October 3, 2011
Last Update Posted : December 13, 2011
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Duloxetine
Drug: Escitalopram
Enrollment 483
Recruitment Details  
Pre-assignment Details

Acute treatment period (1 week): Participants randomized to switch to 60 milligrams (mg) duloxetine once daily (QD) by mouth (po) or 10 mg escitalopram QD po.

Optimization period (7 weeks): Participants given duloxetine or escitalopram in acute study period may optimize their QD po doses (60-120 mg duloxetine QD po; 10-20 mg escitalopram QD po).

Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks. Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Period Title: Acute Treatment Period
Started 244 239
Completed 229 227
Not Completed 15 12
Reason Not Completed
Adverse Event             3             4
Entry Criteria Not Met             1             2
Protocol Violation             2             0
Sponsor Decision             0             1
Withdrawal by Subject             9             5
Period Title: Optimization Period
Started 229 227
Completed 203 204
Not Completed 26 23
Reason Not Completed
Adverse Event             7             9
Death             0             1
Lack of Efficacy             5             3
Lost to Follow-up             0             1
Physician Decision             1             0
Protocol Violation             3             1
Withdrawal by Subject             10             8
Arm/Group Title Duloxetine Escitalopram Total
Hide Arm/Group Description Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks. Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 244 239 483
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 244 participants 239 participants 483 participants
44.15  (13.81) 44.93  (12.89) 44.54  (13.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 239 participants 483 participants
Female
187
  76.6%
179
  74.9%
366
  75.8%
Male
57
  23.4%
60
  25.1%
117
  24.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 244 participants 239 participants 483 participants
Hispanic or Latino
45
  18.4%
44
  18.4%
89
  18.4%
Not Hispanic or Latino
199
  81.6%
195
  81.6%
394
  81.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 239 participants 483 participants
American Indian or Alaska Native 34 37 71
Asian 90 82 172
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 0 1 1
White 120 119 239
More than one race 1 0 1
Unknown or Not Reported 0 0 0
[1]
Measure Description: One participant selected 2 races. Therefore, the total number of participants in the race category will be larger than the number of participants in the baseline table.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 239 participants 483 participants
Australia 24 25 49
Canada 44 43 87
China 47 41 88
Italy 23 22 45
Korea, Republic of 18 15 33
Mexico 42 43 85
Russian Federation 23 25 48
Taiwan 23 25 48
Taking Escitalopram 3 Months Prior to Study Entry   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 244 participants 239 participants 483 participants
Yes 67 59 126
No 177 180 357
[1]
Measure Description: Previous therapy status is defined as the number of participants who had taken escitalopram 3 months prior to study entry.
Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
46.28  (7.82) 46.34  (8.14) 46.31  (7.97)
[1]
Measure Description: The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy.
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
10.57  (3.49) 10.29  (3.68) 10.43  (3.59)
[1]
Measure Description: The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Montgomery-Asberg Depression Rating Scale (MADRS) Item 8 Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
1.82  (1.10) 1.82  (1.15) 1.82  (1.13)
[1]
Measure Description: The MADRS Item 8 assesses participants' inability to feel, through evaluation of their interest in their surroundings or activities that normally give pleasure, as well as their ability to react with adequate emotion to circumstances or people. The score ranges from 0 (normal interest in the surroundings and in other people) to 6 (the experience of being emotionally paralyzed, inability to feel anger, grief or pleasure and a complete or even painful failure to feel for close relatives and friends).
Clinical Global Impressions of Severity Scale (CGI-S)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
3.05  (0.91) 3.04  (0.91) 3.05  (0.91)
[1]
Measure Description: The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
10.72  (4.92) 10.51  (4.95) 10.62  (4.93)
[1]
Measure Description: RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity.
The Massachusetts General Hospital Cognitive and Physical functioning Questionnaire (MGH-CPFQ) Total   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
24.78  (5.73) 24.69  (5.83) 24.73  (5.78)
[1]
Measure Description: The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. It assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each of the 7 items is scored on a 6-point scale ranging from "greater than normal" (score of 1) to "normal" (score of 2), to "totally absent" (score of 6). Total scores range from 7 to 42. Higher scores indicate greater disease severity.
Sheehan Disability Scale - Total Score (SDS Total)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 244 participants 239 participants 483 participants
15.32  (6.76) 14.62  (6.39) 14.98  (6.58)
[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.
1.Primary Outcome
Title Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8
Hide Description The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 213 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-13.88  (0.54) -13.50  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments [Not Specified]
Method Mixed Models Analysis
Comments The "Kenward-Roger approximation" was used in the MMRM model.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.38
Confidence Interval (2-Sided) 95%
-1.87 to 1.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8
Hide Description AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 213 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Cognition Items Total Score -6.49  (0.26) -6.25  (0.26)
Behavior Items Total Score -3.35  (0.15) -3.25  (0.16)
Emotional Items Total Score -1.66  (0.08) -1.58  (0.08)
Other Items Total Score -2.43  (0.10) -2.44  (0.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.504
Comments This is the p-value for Cognition Items Total Score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.665
Comments This is the p-value for the Behavior Items Total Score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.489
Comments This is the p-value for Emotional Items Total Score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.945
Comments This is the p-value for Other Items Total Score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
3.Secondary Outcome
Title Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8
Hide Description RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline at and least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 212 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
RSAT Total Score -5.50  (0.26) -4.98  (0.26)
Energy Level -1.33  (0.07) -1.19  (0.07)
Motivation and Interest -1.41  (0.06) -1.29  (0.06)
Cognitive Functioning -0.90  (0.06) -0.80  (0.06)
Weight Gain -0.25  (0.05) -0.11  (0.05)
Sleep -0.48  (0.08) -0.55  (0.08)
Sexual Functioning -0.62  (0.07) -0.60  (0.07)
Affect -0.53  (0.04) -0.50  (0.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.157
Comments This is the p-value for the Total Score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments This is the p-value for the Energy Level score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.184
Comments This is the p-value for the Motivation and Interest score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.226
Comments This is the p-value for the Cognitive Functioning score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments This is the p-value for the Weight Gain score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.466
Comments This is the p-value for the Sleep score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.822
Comments This is the p-value for the Sexual Functioning score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.599
Comments This is the p-value for the Affect score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
4.Secondary Outcome
Title Patient’s Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8
Hide Description The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 213 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.59  (0.08) 2.55  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.723
Comments This is the p-value for the PGI-I.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
5.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8
Hide Description The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 213 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.86  (0.06) -0.93  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.410
Comments [Not Specified]
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
6.Secondary Outcome
Title Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8
Hide Description MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 213 210
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score -4.21  (0.32) -4.14  (0.33)
Item 8 (Inability to Feel) -1.01  (0.06) -0.90  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.880
Comments This is the p-value for the Total Score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.224
Comments This is the p-value for the Item 8 (Inability to Feel) score.
Method Mixed Models Analysis
Comments The “Kenward-Roger approximation” was used in the MMRM model.
7.Secondary Outcome
Title Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8
Hide Description The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 ("greater than normal") to 2 ("normal") to 6 ("totally absent"). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 221 214
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Total Score -6.96  (0.34) -6.91  (0.35)
Motivation/Interest/Enthusiasm Score -1.34  (0.07) -1.35  (0.07)
Wakefulness/Alertness Score -0.96  (0.06) -1.00  (0.06)
Energy Score -1.28  (0.07) -1.21  (0.07)
Ability to Focus/Sustain Attention Score -0.99  (0.06) -1.02  (0.06)
Ability to Remember/Recall Information Score -0.91  (0.06) -0.85  (0.06)
Ability to Find Words Score -0.69  (0.05) -0.71  (0.05)
Sharpness/Mental Acuity Score -0.79  (0.05) -0.85  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments This is the p-value for the Total Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.882
Comments This is the p-value for the Motivation/Interest/Enthusiasm Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.657
Comments This is the p-value for the Wakefulness/Alertness Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.457
Comments This is the p-value for the Energy Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.737
Comments This is the p-value for the Ability to Focus/Sustain Attention Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.404
Comments This is the p-value for the Ability to Remember/Recall Information Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.808
Comments This is the p-value for the Ability to Find Words Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments This is the p-value for the Sharpness/Mental Acuity Score.
Method ANCOVA
Comments ANCOVA main effect F test
8.Secondary Outcome
Title Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8
Hide Description The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline.
Time Frame Baseline, 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 211 209
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
SDS Total Score -7.55  (0.40) -7.67  (0.41)
SDS Work Score -2.42  (0.14) -2.29  (0.14)
SDS Family Score (N=212, 210) -2.51  (0.16) -2.67  (0.16)
SDS Social Score (N=212, 210) -2.56  (0.16) -2.72  (0.16)
SDS Days Lost Score (N=208, 204) -0.55  (0.11) -0.60  (0.11)
SDS Days Unproductive Score (N=209, 205) -1.78  (0.13) -1.89  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.821
Comments This is the p-value for the SDS Total Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.491
Comments This is the p-value for the Item 1 (Work) Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments This is the p-value for the Item 2 (Family) Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments This is the p-value for the Item 3 (Social) Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments This is the p-value for the Item 4 (Days Lost) Score.
Method ANCOVA
Comments ANCOVA main effect F test
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments This is the p-value for the Item 5 (Days Underproductive) Score.
Method ANCOVA
Comments ANCOVA main effect F test
9.Secondary Outcome
Title Percentage of Participants Who Relapsed During 8 Weeks
Hide Description Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame Baseline through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with a baseline and at least 1 post-baseline result.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 243 237
Measure Type: Number
Unit of Measure: percentage of participants
11.9 11.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.776
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks
Hide Description The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored).
Time Frame Baseline through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants in each treatment group having time to relapse plus the participants censored. Duloxetine had 200 participants censored and escitalopram had 199 participants censored.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 229 225
Measure Type: Number
Unit of Measure: days
Minimum Number of Days from Baseline 4.00 4.00
Maximum Number of Days from Baseline 81.00 68.00
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments The log-rank test was conducted using Kaplan-Meier Product-Limit method.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.691
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks
Hide Description Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion.
Time Frame Baseline through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description:
Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
Overall Number of Participants Analyzed 244 239
Measure Type: Number
Unit of Measure: percentage of participants
2.0 1.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine, Escitalopram
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.724
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Duloxetine Escitalopram
Hide Arm/Group Description Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks. Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
All-Cause Mortality
Duloxetine Escitalopram
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Escitalopram
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/244 (1.23%)      3/239 (1.26%)    
Gastrointestinal disorders     
Melaena  1  0/244 (0.00%)  0 1/239 (0.42%)  1
Hepatobiliary disorders     
Cholelithiasis  1  1/244 (0.41%)  1 0/239 (0.00%)  0
Nervous system disorders     
Syncope  1  0/244 (0.00%)  0 1/239 (0.42%)  1
Psychiatric disorders     
Depression  1  1/244 (0.41%)  1 0/239 (0.00%)  0
Insomnia  1  0/244 (0.00%)  0 1/239 (0.42%)  1
Suicide attempt  1  0/244 (0.00%)  0 1/239 (0.42%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/244 (0.41%)  1 0/239 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Duloxetine Escitalopram
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   130/244 (53.28%)      100/239 (41.84%)    
Gastrointestinal disorders     
Constipation  1  23/244 (9.43%)  23 9/239 (3.77%)  9
Dry mouth  1  13/244 (5.33%)  14 8/239 (3.35%)  8
Nausea  1  26/244 (10.66%)  26 28/239 (11.72%)  28
Metabolism and nutrition disorders     
Decreased appetite  1  8/244 (3.28%)  8 3/239 (1.26%)  3
Nervous system disorders     
Dizziness  1  7/244 (2.87%)  8 15/239 (6.28%)  15
Headache  1  16/244 (6.56%)  16 20/239 (8.37%)  20
Somnolence  1  14/244 (5.74%)  15 8/239 (3.35%)  9
Psychiatric disorders     
Anxiety  1  9/244 (3.69%)  9 1/239 (0.42%)  1
Insomnia  1  17/244 (6.97%)  21 10/239 (4.18%)  10
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  8/244 (3.28%)  8 2/239 (0.84%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00985504     History of Changes
Other Study ID Numbers: 13018
F1J-CR-HMGM ( Other Identifier: Eli Lilly and Company )
First Submitted: September 25, 2009
First Posted: September 28, 2009
Results First Submitted: August 29, 2011
Results First Posted: October 3, 2011
Last Update Posted: December 13, 2011