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Terminated Phase 2 Interventional Results available

Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

ClinicalTrials.gov ID: NCT04634669

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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 4:24 AM EDT

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures

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

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 23, 2020 (Actual)
Primary completion
Feb 18, 2022 (Actual)
Completion
Mar 4, 2022 (Actual)
Last update posted
Jan 28, 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 28, 2026 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04634669 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →