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NCT04019704 Clinical Trial

A Trial of AXS-05 in Patients With Major Depressive Disorder

Depression Clinical Trial

— GEMINI  

Official title:
AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04019704
Other study ID # AXS-05-MDD-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 20, 2019
Est. completion date December 5, 2019

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

A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Description:

This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 327
Est. completion date December 5, 2019
Est. primary completion date November 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria: - Age 18 - 65 - Currently meets DSM-5 criteria for MDD - Body Mass Index between 18 and 40 kg/m^2, inclusive Key Exclusion Criteria: - Suicide risk - History of treatment resistance in current depressive episode - History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months - Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05
Oral AXS-05 tablets, taken daily for 6 weeks.
• Placebo
Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.

Locations
Country Name City State
United States Clinical Research Site Atlanta Georgia
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 Coral Springs Florida
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 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 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 Phoenix Arizona
United States Clinical Research Site Redlands California
United States Clinical Research Site Riverside California
United States Clinical Research Site Rochester New York
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 Change in MADRS Total Score From Baseline to Week 6 The primary objective of the study was to evaluate the efficacy of AXS-05 as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms from baseline to Week 6. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. 6 weeks
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