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NCT04634669 Clinical Trial

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

Major Depressive Disorder Clinical Trial

Official title:
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Treatment Resistant Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04634669
Other study ID # AXS-05-TRD-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 23, 2020
Est. completion date March 4, 2022

Study information
Verified date March 2023
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date March 4, 2022
Est. primary completion date March 4, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features - Continued depression despite treatment with antidepressants in the current depressive episode - Agree to use adequate method of contraception for the duration of the study - Additional criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05 (dextromethorphan-bupropion)
- AXS-05 tablet, taken daily (up to 15 months)

Locations
Country Name City State
United States Clinical Research Site Berlin New Jersey
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Chicago Illinois
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Everett Washington
United States Clinical Research Site Friendswood Texas
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Little Rock Arkansas
United States Clinical Research Site Media Pennsylvania
United States Clinical Research Site Miami Florida
United States Clinical Research Site Middleburg Heights Ohio
United States Clinical Research Site North Miami Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Raleigh North Carolina
United States Clinical Research Site Redlands California
United States Clinical Research Site Rochester New York
United States Clinical Research Site Sherman Oaks California
United States Clinical Research Site Staten Island New York
United States Clinical Research Site Upland California

Sponsors (1)
Lead Sponsor Collaborator
Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Montgomery-Åsberg Depression Rating Scale (MADRS) The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. Up to 15 months
Primary Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05 Up to 15 months
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