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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01421342
The ClinicalTrials.gov registry entry for NCT01421342 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,522 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Switching: Bupropion-SR is the first listed.
NCT01421342 reports 0 study locations.
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.
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