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

NCT ID: NCT04634669

Last Updated: 2026-01-28

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-23

Study Completion Date

2022-03-04

Brief Summary

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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

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Detailed Description

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Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.

Conditions

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Treatment Resistant Depression Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AXS-05 (dextromethorphan-bupropion)

Group Type EXPERIMENTAL

AXS-05 (dextromethorphan-bupropion)

Intervention Type DRUG

\- Titrated to AXS-05 (45 mg dextromethorphan HBr / 105 mg bupropion HCl) twice daily (up to 15 months)

Interventions

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AXS-05 (dextromethorphan-bupropion)

\- Titrated to AXS-05 (45 mg dextromethorphan HBr / 105 mg bupropion HCl) twice daily (up to 15 months)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features and with prior antidepressant treatment failure
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axsome Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Research Site

Little Rock, Arkansas, United States

Site Status

Clinical Research Site

Redlands, California, United States

Site Status

Clinical Research Site

Sherman Oaks, California, United States

Site Status

Clinical Research Site

Upland, California, United States

Site Status

Clinical Research Site

Miami, Florida, United States

Site Status

Clinical Research Site

Miami Lakes, Florida, United States

Site Status

Clinical Research Site

Orlando, Florida, United States

Site Status

Clinical Research Site

Chicago, Illinois, United States

Site Status

Clinical Research Site

Boston, Massachusetts, United States

Site Status

Clinical Research Site

Berlin, New Jersey, United States

Site Status

Clinical Research Site

Rochester, New York, United States

Site Status

Clinical Research Site

Staten Island, New York, United States

Site Status

Clinical Research Site

Hickory, North Carolina, United States

Site Status

Clinical Research Site

Raleigh, North Carolina, United States

Site Status

Clinical Research Site

Cincinnati, Ohio, United States

Site Status

Clinical Research Site

Middleburg Heights, Ohio, United States

Site Status

Clinical Research Site

Media, Pennsylvania, United States

Site Status

Clinical Research Site

Dallas, Texas, United States

Site Status

Clinical Research Site

Friendswood, Texas, United States

Site Status

Clinical Research Site

Everett, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.axsome.com

Axsome Therapeutics Website

Other Identifiers

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AXS-05-TRD-202

Identifier Type: -

Identifier Source: org_study_id

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