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NCT01421342 · ClinicalTrials.gov registry record · Phase 3
VA Augmentation and Switching Treatments for Improving Depression Outcomes
A Phase 3 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,522
- Enrollment target
NCT01421342: Completed Phase 3 study, sponsored by VA Office of Research and Development.
NCT01421342 is a Phase 3 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 1,522 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01421342, a Phase 3 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,522 participants
- Enrollment target
Study Summary
The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepressant with aripiprazole or with bupropion-slow release (SR) vs. switching treatment to bupropion-SR monotherapy on symptom remission in Veterans with Major Depressive Disorder (MDD) who have not achieved optimal response after an adequate trial on antidepressant (a selective serotonin reuptake inhibitor \[SSRI\] or serotonin and norepinephrine reuptake inhibitor \[SNRI\] or mirtazapine) monotherapy. The secondary objectives are to compare the acute (up to 12 weeks) and long term (up to 36 weeks) efficacy, safety, effects on functioning, suicidality, quality of life, anxiety and other associated symptoms, costs and cost-effectiveness of each of the three treatments.
Primary Outcome
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.
Interventions
- DRUG Switching: Bupropion-SR
- DRUG Augmenting: Antidepressant + Bupropion-SR
- DRUG Augmenting: Antidepressant + Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,522 participants |
| Start Date | 2012-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
What the finished NCT01421342 record still lists
NCT01421342 is an interventional study that assigns participants to a tested intervention. Its 1,522 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% higher).
The record links to 0 conditions, and to 3 interventions - of which Switching: Bupropion-SR is the first listed.
NCT01421342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01421342 about?
NCT01421342 is a clinical study titled "VA Augmentation and Switching Treatments for Improving Depression Outcomes". The overall purpose is to determine research based 'next-steps' for outpatients with major depressive disorder who have not had satisfactory outcomes to standard 'first-step' treatments. The primary objective is to compare the acute (up to 12 weeks) treatment effectiveness of augmenting an antidepre...
What is the current status of trial NCT01421342?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,522 participants. The study started on 2012-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01421342?
The interventions under investigation include: Switching: Bupropion-SR (DRUG), Augmenting: Antidepressant + Bupropion-SR (DRUG), Augmenting: Antidepressant + Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT01421342?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01421342's enrollment target sits among peer trials
1,522 156th of 2000 higher than 1,845 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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