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NCT04039022 · ClinicalTrials.gov registry record · Phase 3
Open-Label Safety Study of AXS-05 in Subjects With Depression
A Phase 3 study of Depression and Major Depressive Disorder, sponsored by Axsome Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 876
- Enrollment target
- 20
- Study locations
NCT04039022 is a Phase 3 study of Depression and Major Depressive Disorder that has completed, run by Axsome Therapeutics. The registered enrollment target is 876 participants, above the 785-participant average among 679 other Depression trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT04039022, a Phase 3 study of Depression and Major Depressive Disorder, has completed, sponsored by Axsome Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 876 participants
- Enrollment target
- 20
- Study locations
Study Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Conditions Studied
Interventions
- DRUG AXS-05 (dextromethorphan and bupropion) oral tablets
Study Locations (20)
California
- Clinical Research Site - Bellflower
- Clinical Research Site - Beverly Hills
- Clinical Research Site - Culver City
- Clinical Research Site - Garden Grove
- Clinical Research Site - Oakland
- Clinical Research Site - Oceanside
- Clinical Research Site - Panorama City
- Clinical Research Site - Redlands
- Clinical Research Site - San Diego
- Clinical Research Site - Sherman Oaks
- Clinical Research Site - Upland
Florida
- Clinical Research Site - Coral Springs
- Clinical Research Site - Hialeah
- Clinical Research Site - Hollywood
- Clinical Research Site - Jacksonville
- Clinical Research Site - Lauderhill
- Clinical Research Site - Miami
Arizona
- Clinical Research Site - Phoenix
Arkansas
- Clinical Research Site - Little Rock
Connecticut
- Clinical Research Site - Cromwell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 876 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2020-10-23 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04039022
The ClinicalTrials.gov registry entry for NCT04039022 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 876 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 785-participant average among 679 other Depression trials with a reported enrollment target (12% higher). The listed sponsor is Axsome Therapeutics, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which AXS-05 (dextromethorphan and bupropion) oral tablets is the first listed.
NCT04039022 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT04039022 about?
NCT04039022 is a clinical study titled "Open-Label Safety Study of AXS-05 in Subjects With Depression". An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
What is the current status of trial NCT04039022?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 876 participants. The study started on 2019-07-08. Estimated completion is 2020-10-23.
What conditions does trial NCT04039022 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder, Treatment-Resistant Depression.
What interventions are being tested in trial NCT04039022?
The interventions under investigation include: AXS-05 (dextromethorphan and bupropion) oral tablets (DRUG).
Who is sponsoring clinical trial NCT04039022?
This trial is sponsored by Axsome Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04039022 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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