Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Axsome Therapeutics.
NCT02741791 is a Phase 3 study that has completed, run by Axsome Therapeutics. The registered enrollment target is 312 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MADRS is used to assess depressive symptomatology during the previous week. Subjects are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating and lack of interest. Each item is scored on a 7-point scale. A score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity.
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 |
What the finished NCT02741791 record still lists
NCT02741791 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which AXS-05 is the first listed.
NCT02741791 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02741791's enrollment target sits among peer trials
312 1102nd of 2000 higher than 895 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04984551 · 312 participants · Phase 2
Impact of Project ECHO on Improving the Quality of Palliative Care in Patients With Advanced Cancer and Their Caregivers in Underserved Areas of Kenya, Nigeria, Ghana, South Africa, India, and Ethiopia
- NCT04999904 · 312 participants · NA
A Proprioceptive Training Program Using an Uneven Terrain Treadmill for Patients With Ankle Instability
- NCT05220332 · 312 participants · NA
Church-based Intervention to Improve Blood Pressure in African Americans
- NCT05434234 · 312 participants · Phase 1
A Study of YL201 in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia