Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)
Public ClinicalTrials.gov record NCT04634669. 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 Treatment Resistant Depression
Study identification
- NCT ID
- NCT04634669
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Axsome Therapeutics, Inc.
- Industry
- Enrollment
- 181 participants
Conditions and interventions
Interventions
- AXS-05 (dextromethorphan-bupropion) Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Sep 22, 2020
- Primary completion
- Feb 17, 2022
- Completion
- Mar 3, 2022
- Last update posted
- Jan 27, 2026
2020 – 2022
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Clinical Research Site | Little Rock | Arkansas | 72209 | — |
| Clinical Research Site | Redlands | California | 92374 | — |
| Clinical Research Site | Sherman Oaks | California | 91403 | — |
| Clinical Research Site | Upland | California | 91786 | — |
| Clinical Research Site | Miami | Florida | 33122 | — |
| Clinical Research Site | Miami Lakes | Florida | 33016 | — |
| Clinical Research Site | Orlando | Florida | 32081 | — |
| Clinical Research Site | Chicago | Illinois | 60634 | — |
| Clinical Research Site | Boston | Massachusetts | 02131 | — |
| Clinical Research Site | Berlin | New Jersey | 08009 | — |
| 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 | Middleburg Heights | Ohio | 44130 | — |
| Clinical Research Site | Media | Pennsylvania | 19063 | — |
| Clinical Research Site | Dallas | Texas | 75243 | — |
| Clinical Research Site | Friendswood | Texas | 77546 | — |
| 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 NCT04634669, 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 Jan 27, 2026 · Synced May 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04634669 live on ClinicalTrials.gov.