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NCT02741791 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder
A Phase 3 study, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 312
- Enrollment target
NCT02741791 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 312 participants.
The verdict
NCT02741791, a Phase 3 study, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 312 participants
- Enrollment target
Study Summary
To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.
Interventions
- DRUG AXS-05
- DRUG Bupropion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 312 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-03-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02741791
The ClinicalTrials.gov registry entry for NCT02741791 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which AXS-05 is the first listed.
NCT02741791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02741791 about?
NCT02741791 is a clinical study titled "A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder". To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatm...
What is the current status of trial NCT02741791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 312 participants. The study started on 2016-03. Estimated completion is 2020-03-20.
What interventions are being tested in trial NCT02741791?
The interventions under investigation include: AXS-05 (DRUG), Bupropion (DRUG).
Who is sponsoring clinical trial NCT02741791?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
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