Open-Label Safety Study of AXS-05 in Subjects With Depression
Public ClinicalTrials.gov record NCT04039022. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder
Study identification
- NCT ID
- NCT04039022
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Axsome Therapeutics, Inc.
- Industry
- Enrollment
- 876 participants
Conditions and interventions
Interventions
- AXS-05 (dextromethorphan and bupropion) oral tablets Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 7, 2019
- Primary completion
- Oct 22, 2020
- Completion
- Oct 22, 2020
- Last update posted
- Oct 11, 2022
2019 – 2020
United States locations
- U.S. sites
- 51
- U.S. states
- 19
- U.S. cities
- 49
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Phoenix | Arizona | 85012 | — |
| Clinical Research Site | Little Rock | Arkansas | 72209 | — |
| Clinical Research Site | Bellflower | California | 90706 | — |
| Clinical Research Site | Beverly Hills | California | 90210 | — |
| Clinical Research Site | Culver City | California | 90230 | — |
| Clinical Research Site | Garden Grove | California | 92845 | — |
| Clinical Research Site | Oakland | California | 94607 | — |
| Clinical Research Site | Oceanside | California | 92056 | — |
| Clinical Research Site | Panorama City | California | 91402 | — |
| Clinical Research Site | Redlands | California | 92374 | — |
| Clinical Research Site | San Diego | California | 92103 | — |
| Clinical Research Site | Sherman Oaks | California | 91403 | — |
| Clinical Research Site | Upland | California | 91786 | — |
| Clinical Research Site | Cromwell | Connecticut | 06416 | — |
| Clinical Research Site | Coral Springs | Florida | 33067 | — |
| Clinical Research Site | Hialeah | Florida | 33012 | — |
| Clinical Research Site | Hollywood | Florida | 33024 | — |
| Clinical Research Site | Jacksonville | Florida | 32256 | — |
| Clinical Research Site | Lauderhill | Florida | 33319 | — |
| Clinical Research Site | Miami | Florida | 33122 | — |
| Clinical Research Site | North Miami | Florida | 33161 | — |
| Clinical Research Site | Orlando | Florida | 32801 | — |
| Clinical Research Site | Atlanta | Georgia | 30328 | — |
| Clinical Research Site | Atlanta | Georgia | 30331 | — |
| Clinical Research Site | Boise | Idaho | 83704 | — |
| Clinical Research Site | Chicago | Illinois | 60634 | — |
| Clinical Research Site | Boston | Massachusetts | 02131 | — |
| Clinical Research Site | Las Vegas | Nevada | 89102 | — |
| Clinical Research Site | Berlin | New Jersey | 08009 | — |
| Clinical Research Site | Cherry Hill | New Jersey | 08002 | — |
| Clinical Research Site | Toms River | New Jersey | 08755 | — |
| Clinical Research Site | Jamaica | New York | 11432 | — |
| Clinical Research Site | Rochester | New York | 14618 | — |
| Clinical Research Site | Staten Island | New York | 10312 | — |
| Clinical Research Site | Hickory | North Carolina | 28601 | — |
| Clinical Research Site | Raleigh | North Carolina | 27609 | — |
| Clinical Research Site | Cincinnati | Ohio | 45215 | — |
| Clinical Research Site | Cincinnati | Ohio | 45219 | — |
| Clinical Research Site | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Site | Oklahoma City | Oklahoma | 73112 | — |
| Clinical Research Site | Media | Pennsylvania | 19063 | — |
| Clinical Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Research Site | Memphis | Tennessee | 38119 | — |
| Clinical Research Site | Austin | Texas | 78712 | — |
| Clinical Research Site | Dallas | Texas | 75243 | — |
| Clinical Research Site | Fort Worth | Texas | 76104 | — |
| Clinical Research Site | Houston | Texas | 77058 | — |
| Clinical Research Site | San Antonio | Texas | 78229 | — |
| Clinical Research Site | Wichita Falls | Texas | 76309 | — |
| Clinical Research Site | Bellevue | Washington | 98007 | — |
| Clinical Research Site | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04039022, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 11, 2022 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04039022 live on ClinicalTrials.gov.