Trial · NCT01421342
VA Augmentation and Switching Treatments for Improving Depression Outcomes
NCT01421342, Phase 3, Completed, VA Office of Research and Development; results first posted 2018-05-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. VA Augmentation and Switching Treatments for Improving Depression Outcomes. Trials, record NCT01421342. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01421342
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- VA Augmentation and Switching Treatments for Improving Depression Outcomes
- NCT number
- NCT01421342
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,522 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Major Depressive Disorder
- Interventions
- Switching: Bupropion-SR, Augmenting: Antidepressant + Bupropion-SR, Augmenting: Antidepressant + Aripiprazole
- First posted
- 2011-08-22
- Last updated
- 2018-05-29
- Results first posted
- 2018-05-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Protocol Remission of Symptoms of Major Depressive Disorder | During acute phase (12 weeks) | Remission of symptoms of major depression during the acute treatment phase (12 weeks) defined as a sustained clinician-rated Quick Inventory of Depressive Symptoms (QIDS-C16) of \<= 5 for two consecutive visits. |
| Secondary | Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase | Within 36 weeks after randomization (initiation of treatment) | Relapse in symptoms of major depression defined as a QIDS-C16 =\> 11 among those achieving remission in the acute phase. |
| Secondary | Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) | During acute phase (up to 12 weeks) | Response measured as reduction in symptom score for major depression defined as: 1. a reduction in QIDS-C16 of 50% or greater |
| Secondary | Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale | During acute phase (up to 12 weeks) | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Protocol Remission of Symptoms of Major Depressive Disorder | During acute phase (12 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase | Within 36 weeks after randomization (initiation of treatment) | 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) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) | During acute phase (up to 12 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale | During acute phase (up to 12 weeks) | Whole randomized cohort by intent-to-treat | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Protocol Remission of Symptoms of Major Depressive Disorder | Switching: Bupropion-SR | 114 | Participants | ||
| Rate of Protocol Remission of Symptoms of Major Depressive Disorder | Augmenting: Antidepressant + Bupropion-SR | 136 | Participants | ||
| Rate of Protocol Remission of Symptoms of Major Depressive Disorder | Augmenting: Antidepressant + Aripiprazole | 146 | Participants | ||
| Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase | Switching: Bupropion-SR | 26 | Participants | ||
| Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase | Augmenting: Antidepressant + Bupropion-SR | 35 | Participants | ||
| Rate of Protocol Relapse of Symptoms of Major Depression After Achieving Remission in the Acute Phase | Augmenting: Antidepressant + Aripiprazole | 37 | Participants | ||
| Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) | Switching: Bupropion-SR | 319 | Participants | ||
| Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) | Augmenting: Antidepressant + Bupropion-SR | 332 | Participants | ||
| Rate of Protocol Response as Reduction in Symptoms of Major Depression (>= 50% Reduction in QIDS-C) | Augmenting: Antidepressant + Aripiprazole | 375 | Participants | ||
| Rate of Protocol Response Measured as a Change in Clinical Global Impression (CGI) - Improvement Scale | Switching: Bupropion-SR | 356 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Acute Treatment Phase (12 Weeks) | STARTED | Switching: Bupropion-SR | 511 | |
| Acute Treatment Phase (12 Weeks) | STARTED | Augmenting: Antidepressant + Bupropion-SR | 506 | |
| Acute Treatment Phase (12 Weeks) | STARTED | Augmenting: Antidepressant + Aripiprazole | 505 | |
| Acute Treatment Phase (12 Weeks) | COMPLETED | Switching: Bupropion-SR | 353 | |
| Acute Treatment Phase (12 Weeks) | COMPLETED | Augmenting: Antidepressant + Bupropion-SR | 378 | |
| Acute Treatment Phase (12 Weeks) | COMPLETED | Augmenting: Antidepressant + Aripiprazole | 406 | |
| Acute Treatment Phase (12 Weeks) | NOT COMPLETED | Switching: Bupropion-SR | 158 | |
| Acute Treatment Phase (12 Weeks) | NOT COMPLETED | Augmenting: Antidepressant + Bupropion-SR | 128 | |
| Acute Treatment Phase (12 Weeks) | NOT COMPLETED | Augmenting: Antidepressant + Aripiprazole | 99 | |
| Completed to Week 12 But Then Withdrawn | STARTED | Switching: Bupropion-SR | 353 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events438
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Switching: Bupropion-SR | 1 | 511 | 1 |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Augmenting: Antidepressant + Bupropion-SR | 0 | 506 | 0 |
| other | Blood and lymphatic system disorders | Blood and lymphatic system disorders | Augmenting: Antidepressant + Aripiprazole | 0 | 505 | 0 |
| other | Cardiac disorders | Cardiac disorders | Switching: Bupropion-SR | 4 | 511 | 4 |
| other | Cardiac disorders | Cardiac disorders | Augmenting: Antidepressant + Bupropion-SR | 2 | 506 | 2 |
| other | Cardiac disorders | Cardiac disorders | Augmenting: Antidepressant + Aripiprazole | 3 | 505 | 3 |
| other | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Switching: Bupropion-SR | 0 | 511 | 0 |
| other | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Augmenting: Antidepressant + Bupropion-SR | 1 | 506 | 1 |
| other | Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | Augmenting: Antidepressant + Aripiprazole | 0 | 0 | 0 |
| other | Ear and labyrinth disorders | Ear and labyrinth disorders | Switching: Bupropion-SR | 4 | 511 | 4 |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Switching: Bupropion-SR | 3 | 511 |
| Total, all-cause mortality | Augmenting: Antidepressant + Bupropion-SR | 1 | 506 |
| Total, all-cause mortality | Augmenting: Antidepressant + Aripiprazole | 4 | 505 |
| Total, other adverse events | Switching: Bupropion-SR | 383 | 511 |
| Total, other adverse events | Augmenting: Antidepressant + Bupropion-SR | 369 | 506 |
| Total, other adverse events | Augmenting: Antidepressant + Aripiprazole | 374 | 505 |
| Total, serious adverse events | Switching: Bupropion-SR | 52 | 511 |
| Total, serious adverse events | Augmenting: Antidepressant + Bupropion-SR | 57 | 506 |
| Total, serious adverse events | Augmenting: Antidepressant + Aripiprazole | 56 | 505 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01421342
GET https://conductscience.org/api/trials/v1/NCT01421342/flow?page=2