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Trial record 11 of 1732 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Behavioral Symptoms

VA Augmentation and Switching Treatments for Improving Depression Outcomes (VAST-D)

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: NCT01421342
Recruitment Status : Completed
First Posted : August 22, 2011
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Drug: Switching: Bupropion-SR
Drug: Augmenting: Antidepressant + Bupropion-SR
Drug: Augmenting: Antidepressant + Aripiprazole
Enrollment 1522
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Hide Arm/Group Description Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Period Title: Acute Treatment Phase (12 Weeks)
Started 511 506 505
Completed 353 378 406
Not Completed 158 128 99
Reason Not Completed
Lack of Efficacy             49             28             13
Adverse Event             53             38             27
Withdrawal by Subject             23             20             13
Death             0             0             3
Lost to Follow-up             6             18             21
Non-adherence             15             7             13
Dure to other illness             3             2             4
Participant moved away             1             6             1
Other reason for withdrawal             8             9             4
Period Title: Completed to Week 12 But Then Withdrawn
Started 353 378 406
Completed 204 253 268
Not Completed 149 125 138
Reason Not Completed
Lack of Efficacy             111             93             88
QIDS Score >=11             7             10             12
Adverse Event             4             3             6
Withdrawal by Subject             13             4             11
Lost to Follow-up             4             3             3
Non-adherence             5             4             5
Due to Other Illness             1             0             2
Participant Moved Away             1             5             5
Oher reason for withdrawal             3             3             4
End of Study Time             0             0             2
Period Title: Continuation of Treatment (Week 12 - 36)
Started 204 253 268
Completed 152 194 203
Not Completed 52 59 65
Reason Not Completed
Lack of Efficacy             11             5             11
Adverse Event             0             6             11
Withdrawal by Subject             7             6             4
Lost to Follow-up             4             11             9
Non-adherence             3             8             4
End of Study Time             15             20             14
Participant moved away             4             1             3
Due to Other Illness             2             2             2
Other reason for withdrawal             6             0             7
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole Total
Hide Arm/Group Description Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Total of all reporting groups
Overall Number of Baseline Participants 511 506 505 1522
Hide Baseline Analysis Population Description
The ASEX (female) version of the questionnaire was specific to females.The ASEX (male) version of the questionnaire was specific to males. Not all females or males completed the questionnaire, therefore, the number of responders is lower than number of participants due to missing responses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
54.5  (12.2) 54.4  (12.2) 54.2  (12.3) 54.4  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
Female
68
  13.3%
81
  16.0%
77
  15.2%
226
  14.8%
Male
443
  86.7%
425
  84.0%
428
  84.8%
1296
  85.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
Hispanic or Latino
0
   0.0%
2
   0.4%
1
   0.2%
3
   0.2%
Not Hispanic or Latino
454
  88.8%
449
  88.7%
459
  90.9%
1362
  89.5%
Unknown or Not Reported
57
  11.2%
55
  10.9%
45
   8.9%
157
  10.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
American Indian or Alaska Native
8
   1.6%
8
   1.6%
6
   1.2%
22
   1.4%
Asian
2
   0.4%
1
   0.2%
4
   0.8%
7
   0.5%
Native Hawaiian or Other Pacific Islander
2
   0.4%
2
   0.4%
1
   0.2%
5
   0.3%
Black or African American
129
  25.2%
115
  22.7%
126
  25.0%
370
  24.3%
White
341
  66.7%
343
  67.8%
338
  66.9%
1022
  67.1%
More than one race
10
   2.0%
20
   4.0%
13
   2.6%
43
   2.8%
Unknown or Not Reported
19
   3.7%
17
   3.4%
17
   3.4%
53
   3.5%
QIDS-C16 Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
16.6  (3.3) 16.6  (3.2) 16.9  (3.3) 16.7  (3.3)
[1]
Measure Description: Quick Inventory of Depression Symptomatology - Clinician rated (QIDS-C16) score: summary score of severity of depression symptoms. (range: 0 [better],27 [worse]), www.ids-qids.org
Patient Health Questionnaire (PHQ-9)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
15.9  (5.2) 16.3  (5.2) 16.3  (5.2) 16.2  (5.2)
[1]
Measure Description: Patient Health Questionnaire (PHQ-9) score is a standard assessment of severity of depression symptoms. (range: 0 [better], 27 [worse]). http://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/patient-health.aspx
CGI - Severity Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 510 participants 505 participants 505 participants 1520 participants
4.5  (1.0) 4.6  (0.9) 4.6  (1.0) 4.6  (1.0)
[1]
Measure Description: Clinical Global Impression (CGI) - Severity score - standard questionnaire for severity of depression symptoms (range: 1 [less severe],7 [more severe]), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2880930/
[2]
Measure Analysis Population Description: Assessments missing for two participants at baseline.
Beck Anxiety Inventory   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 510 participants 506 participants 503 participants 1519 participants
18.6  (11.1) 19.0  (11.4) 19.7  (11.3) 19.1  (11.3)
[1]
Measure Description: Beck Anxiety Inventory (BAI) - This is a standard questionnaire to assess anxiety of participant. The mean and standard deviation of the total score (range: 0 [low anxiety - better], 63 [higher anxiety - worse] ), https://www.beckinstitute.org/get-informed/tools-and-resources/professionals/patient-assessment-tools/
[2]
Measure Analysis Population Description: Assessment missing for three participants at baseline
Arizona Sexual Experiences Scale (Female)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 64 participants 76 participants 73 participants 213 participants
4.2  (1.1) 4.2  (1.1) 4.2  (1.2) 4.2  (1.1)
[1]
Measure Description: This is a standard questionnaire for quantification of sexual dysfunction. The mean and standard deviation of the total score are presented here (range 5-30; 5 indicates better experiences, 30 indicates worse experiences) - this version is specific to females.
[2]
Measure Analysis Population Description: The ASEX (female) version of the questionnaire was specific to females. Not all females completed the questionnaire, therefore, the number of responders is lower than number of female participants due to missing responses.
Arizona Sexual Experiences Scale (male)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Participants
Number Analyzed 434 participants 418 participants 421 participants 1273 participants
4.1  (1.1) 4.1  (1.1) 4.1  (1.2) 4.1  (1.1)
[1]
Measure Description: This is a standard questionnaire for quantification of sexual dysfunction. Mean and standard deviation of total score are presented here (range 5-30; 5 indicates better experiences, 30 indicates worse experiences) - this version specific to males. Not all males completed the questionnaire, number of responders is lower than number of males due to missing responses.
[2]
Measure Analysis Population Description: The ASEX (male) version of the questionnaire was specific to males. Not all males completed the questionnaire, therefore, the number of responders is lower than number of male participants due to missing responses.
PTSD   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
248
  48.5%
244
  48.2%
225
  44.6%
717
  47.1%
[1]
Measure Description: Post-traumatic stress disorder (PTSD) determined by PTSD panel on MINI International Neuropsychiatric Interview (MINI) V6.0.0 following the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria, administered prior to randomization - current diagnosis.
EuroQol Health State Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 511 participants 505 participants 505 participants 1521 participants
54.7  (20.5) 52.7  (19.8) 54.0  (20.8) 53.8  (20.4)
[1]
Measure Description: General health-related quality of life (range 0 - 100; 0 indicates worse health state, 100 indicates best possible health state)
[2]
Measure Analysis Population Description: Assessment missing for one participant at baseline
Quality of Life Enjoyment and Satisfaction Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
41.4  (13.8) 40.3  (14.8) 40.1  (14.8) 40.6  (14.5)
[1]
Measure Description: Quality of Life Enjoyment and Satisfaction (Q_LES_Q) Score - adjusted for percent of maximum score - measures general quality of life (percent of raw score ranges 0 - 100; 0 indicates worse quality, 100 indicates best quality)
Cumulative Illness Rating Scale (CIRS) Severity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 511 participants 506 participants 505 participants 1522 participants
11.4  (5.5) 11.1  (4.9) 11.0  (5.1) 11.2  (5.2)
[1]
Measure Description: Standard questionnaire to assess comorbidities (range 0-56; 0 indicates least comorbidities [none], 56 greatest severity of comorbidities)
1.Primary Outcome
Title Rate of Protocol Remission of Symptoms of Major Depressive Disorder
Time Frame During acute phase (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Hide Arm/Group Description:
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Overall Number of Participants Analyzed 511 506 505
Measure Type: Count of Participants
Unit of Measure: Participants
114
  22.3%
136
  26.9%
146
  28.9%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.076
Comments Co-primary hypothesis: After ordering results from largest p-value to smallest (Hochberg approach) the comparison of Augmenting Antidepressant+Bupropion with Switching to Bupropion-SR was performed at the 0.05 significance level.
Method Regression, Logistic
Comments Stratified by participating medical center
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.31
Confidence Interval (2-Sided) 95%
0.97 to 1.75
Estimation Comments Represents relative odds of remission for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments Co-primary hypothesis: After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Co-primary hypothesis: Second ordered test after ordering largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.
Method Regression, Logistic
Comments Stratified by participating medical center
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
1.06 to 1.89
Estimation Comments Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Augmenting: Antidepressant + Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments If either if the first two hypothesis tests for the co-primary hypotheses were significant, perform the test of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.46
Comments Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole vs. Augmentation Antidepressant + Bupropion-SR was evaluated at the 0.05 significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.11
Confidence Interval (2-Sided) 95%
0.84 to 1.48
Estimation Comments Represents relative odds of remission for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR
2.Secondary Outcome
Title Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase
Time Frame Within 36 weeks after randomization (initiation of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population is the cohort of participants who met the criteria for protocol remission during the Acute Phase (first 12 Weeks of follow-up)
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Hide Arm/Group Description:
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Overall Number of Participants Analyzed 114 136 146
Measure Type: Count of Participants
Unit of Measure: Participants
26
  22.8%
35
  25.7%
37
  25.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.36
Confidence Interval (2-Sided) 95%
0.78 to 2.39
Estimation Comments Represents relative odds of relapse for Augmentation Antidepressant + Bupropion-SR / Switching to Bupropion-SR
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.65 to 1.94
Estimation Comments Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Augmenting: Antidepressant + Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.58 to 1.59
Estimation Comments Represents relative odds of relapse for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR
3.Secondary Outcome
Title Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C)
Hide Description Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater
Time Frame During acute phase (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Hide Arm/Group Description:
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Overall Number of Participants Analyzed 511 506 505
Measure Type: Count of Participants
Unit of Measure: Participants
319
  62.4%
332
  65.6%
375
  74.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR
Comments After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Regression, Logistic
Comments Stratified by participating medical center
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.89 to 1.50
Estimation Comments Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Regression, Logistic
Comments Stratified by participating medical center (site)
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.74
Confidence Interval (2-Sided) 95%
1.33 to 2.29
Estimation Comments Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Augmenting: Antidepressant + Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.
Method Regression, Logistic
Comments Stratified by participating medical center
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.17 to 2.05
Estimation Comments Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR
4.Secondary Outcome
Title Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale
Hide Description Clinical assessment of a participant's level of depression and treatment response assessed by the Clinical Global Impression - Improvement (CGI -I) Scale, a 7-point clinician rating scale of improvement from baseline in severity of depression (Guy 1976). A secondary outcome measure of response was defined as achieving a score of 2 (much improved) or 1 (very much improved).
Time Frame During acute phase (up to 12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Whole randomized cohort by intent-to-treat
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Hide Arm/Group Description:
Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Overall Number of Participants Analyzed 511 506 505
Measure Type: Count of Participants
Unit of Measure: Participants
356
  69.7%
376
  74.3%
400
  79.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Bupropion with Switching to Bupropion was performed at the 0.05 significance level.
Method Regression, Logistic
Comments Stratified by participating medical center
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.26
Confidence Interval (2-Sided) 95%
0.95 to 1.68
Estimation Comments Represents relative odds of response for Augmentation Antidepressant + Bupropion / Switching to Bupropion
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Switching: Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments After ordering results form largest p-value to smallest (Hochberg approach) the comparison of Augmentation Antidepressant + Aripiprazole with Switching to Bupropion-SR was performed at the 0.025 significance level.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Logistic
Comments Stratified by participating medical center
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.70
Confidence Interval (2-Sided) 95%
1.26 to 2.29
Estimation Comments Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Switching to Bupropion-SR
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Augmenting: Antidepressant + Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments Following the gate-keeping strategy of the analysis plan, complete the comparison of Augmentation Antidepressant + Aripiprazole with Augmentation Antidepressant + Bupropion-SR at the 0.05 significance level.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
1.01 to 1.86
Estimation Comments Represents relative odds of response for Augmentation Antidepressant + Aripiprazole / Augmentation Antidepressant + Bupropion-SR
Time Frame Serious adverse events were collected from the time of enrollment to withdrawal (up to 36 weeks after randomization) with one month of surveillance after withdrawal. Non-serious adverse events were collected from the time of randomization to withdrawal (up to 36 weeks after randomization).
Adverse Event Reporting Description A non-serious adverse events was reported if it was among the symptoms prompted for at each scheduled follow-up or if it was a symptom assessed as possibly related to s study medication.
 
Arm/Group Title Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Hide Arm/Group Description

Switching: Bupropion-SR

Switching: Bupropion-SR: Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Bupropion-SR

Augmenting: Antidepressant + Bupropion-SR: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.

And

Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

Augmenting: Antidepressant + Aripiprazole

Augmenting: Antidepressant + Aripiprazole: Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.

And

Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.

All-Cause Mortality
Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/511 (0.59%)      1/506 (0.20%)      4/505 (0.79%)    
Show Serious Adverse Events Hide Serious Adverse Events
Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/511 (10.18%)      57/506 (11.26%)      56/505 (11.09%)    
Blood and lymphatic system disorders       
Haemorrhagic disorder  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Cardiac disorders       
Cardiac disorders (total)  1  7/511 (1.37%)  7 4/506 (0.79%)  4 8/505 (1.58%)  8
Acute myocardial infarction  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Angina pectoris  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Atrial fibrillation  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Cardiac failure acute  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Cardiac failure congestive  1  1/511 (0.20%)  1 1/506 (0.20%)  1 2/505 (0.40%)  2
Cardiomyopathy  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Coronary artery disease  1  2/511 (0.39%)  2 0/506 (0.00%)  0 0/505 (0.00%)  0
Coronary artery occlusion  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Coronary artery stenosis  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Intracardiac thrombus  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Myocardial infarction  1  1/511 (0.20%)  1 0/506 (0.00%)  0 1/505 (0.20%)  1
Nodal rhythm  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Sinus bradycardia  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Sinus node dysfunction  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Endocrine disorders       
Hyperaldosteronism  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Gastrointestinal disorders       
Gastrointestinal disorders (total)  1  3/511 (0.59%)  3 2/506 (0.40%)  3 2/505 (0.40%)  2
Abdominal hernia  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Diverticulum intestinal haemorrhagic  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Gastric perforation  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Gastrooesophageal reflux disease  1  1/511 (0.20%)  1 0/506 (0.00%)  0 1/505 (0.20%)  1
Large intestine polyp  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Oesophagitis ulcerative  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Pancreatic pseudocyst  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
General disorders       
General disorders and administration site conditions (total)  1  4/511 (0.78%)  6 2/506 (0.40%)  2 5/505 (0.99%)  6
Adverse drug reaction  1  1/511 (0.20%)  1 1/506 (0.20%)  1 0/505 (0.00%)  0
Asthenia  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Chest pain  1  1/511 (0.20%)  1 0/506 (0.00%)  0 3/505 (0.59%)  4
Device malfunction  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Hernia obstructive  1  1/511 (0.20%)  3 0/506 (0.00%)  0 0/505 (0.00%)  0
Non-cardiac chest pain  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Sudden death  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Hepatobiliary disorders       
Biliary colic  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Cholecystitis  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Cholecystitis acute  1  0/511 (0.00%)  0 1/506 (0.20%)  1 1/505 (0.20%)  1
Gallbladder disorder  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Infections and infestations       
Infections and infestations (total)  1  6/511 (1.17%)  6 10/506 (1.98%)  11 12/505 (2.38%)  14
Abscess  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Arthritis bacterial  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Bronchitis  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Cellulitis of male external genital organ  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Diverticulitis  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Eczema infected  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Erysipelas  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Infectious colitis  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Infective tenosynovitis  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Perirectal abscess  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Pneumonia  1  2/511 (0.39%)  2 4/506 (0.79%)  4 3/505 (0.59%)  3
Pneumonia staphylococcal  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Postoperative wound infection  1  0/511 (0.00%)  0 1/506 (0.20%)  1 1/505 (0.20%)  1
Pyelonephritis  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Sinusitis  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Tooth abscess  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Urinary tract infection  1  1/511 (0.20%)  1 0/506 (0.00%)  0 3/505 (0.59%)  3
Urinary tract infection bacterial  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Injury, poisoning and procedural complications       
Accident at work  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Back injury  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Cardiac valve replacement complication  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Fall  1  0/511 (0.00%)  0 2/506 (0.40%)  2 0/505 (0.00%)  0
Injury  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Joint injury  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Post procedural haemorrhage  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Procedural complication  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Road traffic accident  1  1/511 (0.20%)  1 1/506 (0.20%)  1 3/505 (0.59%)  3
Investigations       
Electrocardiogram QT prolonged  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Metabolism and nutrition disorders       
Diabetic ketoacidosis  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Hyperglycaemia  1  0/511 (0.00%)  0 1/506 (0.20%)  1 2/505 (0.40%)  2
Hypokalaemia  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthritis  1  1/511 (0.20%)  1 1/506 (0.20%)  1 1/505 (0.20%)  1
Arthropathy  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Back pain  1  0/511 (0.00%)  0 1/506 (0.20%)  1 1/505 (0.20%)  1
Cervical spinal stenosis  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Intervertebral disc degeneration  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Lumbar spinal stenosis  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Musculoskeletal chest pain  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Osteoarthritis  1  0/511 (0.00%)  0 2/506 (0.40%)  2 3/505 (0.59%)  3
Rhabdomyolysis  1  1/511 (0.20%)  1 1/506 (0.20%)  1 0/505 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Lung adenocarcinoma stage I  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Lung neoplasm malignant  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Parathyroid tumour benign  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Prostate cancer  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Prostate cancer stage I  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Nervous system disorders       
Nervous system disorders (total)  1  7/511 (1.37%)  7 3/506 (0.59%)  4 3/505 (0.59%)  4
Carpal tunnel syndrome  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Diabetic neuropathy  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Drug withdrawal headache  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Guillain-Barre syndrome  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Lacunar infarction  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Seizure  1  2/511 (0.39%)  2 2/506 (0.40%)  3 0/505 (0.00%)  0
Serotonin syndrome  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Syncope  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Transient ischaemic attack  1  2/511 (0.39%)  2 0/506 (0.00%)  0 1/505 (0.20%)  1
Psychiatric disorders       
Psychiatric disorders (total)  1  15/511 (2.94%)  15 14/506 (2.77%)  17 13/505 (2.57%)  16
Aggression  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Alcohol abuse  1  1/511 (0.20%)  1 0/506 (0.00%)  0 2/505 (0.40%)  2
Alcoholism  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Anxiety  1  0/511 (0.00%)  0 1/506 (0.20%)  1 1/505 (0.20%)  1
Completed suicide  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Delirium  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Drug abuse  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Homicidal ideation  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Self-injurious ideation  1  0/511 (0.00%)  0 1/506 (0.20%)  1 1/505 (0.20%)  1
Somatisation disorder  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Substance abuse  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Substance-induced psychotic disorder  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Suicidal ideation  1  8/511 (1.57%)  8 10/506 (1.98%)  11 5/505 (0.99%)  5
Suicide attempt  1  3/511 (0.59%)  3 1/506 (0.20%)  1 3/505 (0.59%)  3
Renal and urinary disorders       
Bladder perforation  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Chronic kidney disease  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  2
Nephrolithiasis  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Renal failure  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Urinary incontinence  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/511 (0.20%)  1 2/506 (0.40%)  3 3/505 (0.59%)  3
Dyspnoea exertional  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Haemoptysis  1  0/511 (0.00%)  0 0/506 (0.00%)  0 0/505 (0.00%)  0
Oropharyngeal pain  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Pulmonary embolism  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/505 (0.00%)  0
Skin and subcutaneous tissue disorders       
Angioedema  1  0/511 (0.00%)  0 2/506 (0.40%)  2 0/505 (0.00%)  0
Surgical and medical procedures       
Alcohol detoxification  1  1/511 (0.20%)  1 1/506 (0.20%)  1 0/505 (0.00%)  0
Drug detoxification  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Vascular disorders       
Arterial occlusive disease  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Arteriosclerosis  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Peripheral arterial occlusive disease  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
1
Term from vocabulary, MedDra 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Switching: Bupropion-SR Augmenting: Antidepressant + Bupropion-SR Augmenting: Antidepressant + Aripiprazole
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   383/511 (74.95%)      369/506 (72.92%)      374/505 (74.06%)    
Blood and lymphatic system disorders       
Blood and lymphatic system disorders  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Cardiac disorders       
Cardiac disorders  1  4/511 (0.78%)  4 2/506 (0.40%)  2 3/505 (0.59%)  3
Congenital, familial and genetic disorders       
Congenital, familial and genetic disorders  1  0/511 (0.00%)  0 1/506 (0.20%)  1 0/0  0
Ear and labyrinth disorders       
Ear and labyrinth disorders  1  4/511 (0.78%)  4 11/506 (2.17%)  12 1/505 (0.20%)  1
Eye disorders       
Eye disorders  1  5/511 (0.98%)  5 10/506 (1.98%)  10 12/505 (2.38%)  14
Gastrointestinal disorders       
Gastrointestinal disorders  1  189/511 (36.99%)  305 157/506 (31.03%)  288 147/505 (29.11%)  230
General disorders       
General disorders and administration site conditions  1  82/511 (16.05%)  100 73/506 (14.43%)  97 105/505 (20.79%)  115
Hepatobiliary disorders       
Hepatobiliary disorders  1  1/511 (0.20%)  1 0/506 (0.00%)  0 0/505 (0.00%)  0
Infections and infestations       
Infections and infestations  1  20/511 (3.91%)  21 10/506 (1.98%)  13 11/505 (2.18%)  12
Injury, poisoning and procedural complications       
Injury, poisoning and procedural complications  1  2/511 (0.39%)  2 11/506 (2.17%)  12 9/505 (1.78%)  10
Investigations       
Investigations  1  25/511 (4.89%)  28 38/506 (7.51%)  41 72/505 (14.26%)  81
Metabolism and nutrition disorders       
Metabolism and nutrition disorders  1  114/511 (22.31%)  134 95/506 (18.77%)  111 113/505 (22.38%)  142
Musculoskeletal and connective tissue disorders       
Musculoskeletal and connective tissue disorders  1  20/511 (3.91%)  21 10/506 (1.98%)  10 17/505 (3.37%)  20
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1  2/511 (0.39%)  2 1/506 (0.20%)  1 0/505 (0.00%)  0
Nervous system disorders       
Nervous system disorders  1  218/511 (42.66%)  383 235/506 (46.44%)  426 239/505 (47.33%)  433
Psychiatric disorders       
Psychiatric disorders  1  224/511 (43.84%)  393 200/506 (39.53%)  349 176/176 (100.00%)  270
Renal and urinary disorders       
Renal and urinary disorders  1  8/511 (1.57%)  8 9/506 (1.78%)  10 6/505 (1.19%)  6
Reproductive system and breast disorders       
Reproductive system and breast disorders  1  1/511 (0.20%)  2 9/506 (1.78%)  9 7/505 (1.39%)  7
Respiratory, thoracic and mediastinal disorders       
Respiratory, thoracic and mediastinal disorders  1  10/511 (1.96%)  11 5/506 (0.99%)  5 10/505 (1.98%)  12
Skin and subcutaneous tissue disorders       
Skin and subcutaneous tissue disorders  1  50/511 (9.78%)  63 48/506 (9.49%)  58 38/505 (7.52%)  45
Social circumstances       
Social circumstances  1  0/511 (0.00%)  0 0/506 (0.00%)  0 1/505 (0.20%)  1
Vascular disorders       
Vascular disorders  1  7/511 (1.37%)  8 3/506 (0.59%)  3 3/505 (0.59%)  3
1
Term from vocabulary, MedDra 18.0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gary R. Johnson, MS
Organization: VA Cooperative Studies Program Coordinating Center, West Haven, CT
Phone: (203) 932-5711 ext 3774
EMail: gary.johnson4@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01421342     History of Changes
Other Study ID Numbers: 576
First Submitted: August 5, 2011
First Posted: August 22, 2011
Results First Submitted: January 29, 2018
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018