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NCT04039022 Clinical Trial

Open-Label Safety Study of AXS-05 in Subjects With Depression

Depression Clinical Trial

Official title:
An Open-Label Study to Assess the Long-term Safety and Efficacy of AXS-05 in Subjects With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04039022
Other study ID # AXS-05-303
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 8, 2019
Est. completion date October 23, 2020

Study information
Verified date September 2022
Source Axsome Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.

Description:

A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one year.

Recruitment information / eligibility
Status Completed
Enrollment 876
Est. completion date October 23, 2020
Est. primary completion date October 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Diagnosis of major depressive disorder, including treatment resistant depression - Body mass index (BMI) between 18 and 40 kg/m^2, inclusive - Agree to use adequate method of contraception for the duration of the study - Additional criteria may apply Exclusion Criteria: - Suicide risk - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study - Additional criteria may apply

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05 (dextromethorphan and bupropion) oral tablets
Oral tablets, taken twice daily for up to 12 months.

Locations
Country Name City State
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Austin Texas
United States Clinical Research Site Bellevue Washington
United States Clinical Research Site Bellflower California
United States Clinical Research Site Berlin New Jersey
United States Clinical Research Site Beverly Hills California
United States Clinical Research Site Boise Idaho
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Cherry Hill New Jersey
United States Clinical Research Site Chicago Illinois
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Cincinnati Ohio
United States Clinical Research Site Coral Springs Florida
United States Clinical Research Site Cromwell Connecticut
United States Clinical Research Site Culver City California
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Everett Washington
United States Clinical Research Site Fort Worth Texas
United States Clinical Research Site Garden Grove California
United States Clinical Research Site Hialeah Florida
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Hollywood Florida
United States Clinical Research Site Houston Texas
United States Clinical Research Site Jacksonville Florida
United States Clinical Research Site Jamaica New York
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Lauderhill Florida
United States Clinical Research Site Little Rock Arkansas
United States Clinical Research Site Media Pennsylvania
United States Clinical Research Site Memphis Tennessee
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 Oakland California
United States Clinical Research Site Oceanside California
United States Clinical Research Site Oklahoma City Oklahoma
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Panorama City California
United States Clinical Research Site Philadelphia Pennsylvania
United States Clinical Research Site Phoenix Arizona
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 San Antonio Texas
United States Clinical Research Site San Diego California
United States Clinical Research Site Sherman Oaks California
United States Clinical Research Site Staten Island New York
United States Clinical Research Site Toms River New Jersey
United States Clinical Research Site Upland California
United States Clinical Research Site Wichita Falls Texas

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

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05 Types and rates of adverse events Up to 12 months
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