Clinical Trials Logo
  1. Home
  2. Major Depressive Disorder
  3. NCT06223880
  4. Details
NCT06223880 Clinical Trial

A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms

Major Depressive Disorder Clinical Trial

Official title:
A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06223880
Other study ID # AXS-05-MDD-401
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 27, 2023
Est. completion date March 2026

Study information
Verified date May 2024
Source Axsome Therapeutics, Inc.
Contact Study Director
Phone +1 (212) 332-5061
Email axs-05-mdd-401@axsome.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind, active-controlled, multi-center study to evaluate the efficacy of AXS-05, compared to bupropion, in preventing the relapse of depressive symptoms in subjects with major depressive disorder (MDD) who have responded to treatment with AXS-05.

Description:

Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. Subjects meeting the response and remission criteria during the open-label period will be randomized (1:1) to the double-blind period to continue treatment with AXS-05 or switch to treatment with bupropion (105 mg) tablets. Randomized subjects will receive double-blind treatment for 26 weeks or until they experience a relapse.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features - Current major depressive episode of at least 4 weeks in duration Exclusion Criteria: - Previously participated in another clinical study of AXS-05; received any investigational drug or device treatment within 30 days of (Screening) Visit 1, or has been prescribed Auvelity. - Unable to comply with study procedures - Medically inappropriate for study participation in the opinion of the investigator

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AXS-05
Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period
• Bupropion
Up to 26 weeks in double-blind period

Locations
Country Name City State
United States Clinical Research Site Atlanta Georgia
United States Clinical Research Site Bellflower California
United States Clinical Research Site Boston Massachusetts
United States Clinical Research Site Brandon Florida
United States Clinical Research Site Brooklyn New York
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 Dallas Texas
United States Clinical Research Site Dallas Texas
United States Clinical Research Site Doral Florida
United States Clinical Research Site Edmond Oklahoma
United States Clinical Research Site Everett Washington
United States Clinical Research Site Hialeah Florida
United States Clinical Research Site Hickory North Carolina
United States Clinical Research Site Jacksonville Florida
United States Clinical Research Site Lafayette California
United States Clinical Research Site Las Vegas Nevada
United States Clinical Research Site Memphis Tennessee
United States Clinical Research Site Miami Florida
United States Clinical Research Site Mount Kisco New York
United States Clinical Research Site New Orleans Louisiana
United States Clinical Research Site New York New York
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 Orlando Florida
United States Clinical Research Site Orlando Florida
United States Clinical Research Site Overland Park Kansas
United States Clinical Research Site Portland Oregon
United States Clinical Research Site Redlands California
United States Clinical Research Site Riverside California
United States Clinical Research Site Saint Charles Missouri
United States Clinical Research Site San Antonio Texas
United States Clinical Research Site San Diego 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 Time from randomization to relapse of depressive symptoms up to 26 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05537558 - Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
Terminated NCT02192099 - Open Label Extension for GLYX13-C-202, NCT01684163 Phase 2
Completed NCT03142919 - Lipopolysaccharide (LPS) Challenge in Depression Phase 2
Recruiting NCT05547035 - Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders N/A
Terminated NCT02940769 - Neurobiological Effects of Light on MDD N/A
Recruiting NCT05892744 - Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression Phase 4
Recruiting NCT05537584 - SMART Trial to Predict Anhedonia Response to Antidepressant Treatment Phase 4
Active, not recruiting NCT05061706 - Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder Phase 3
Completed NCT04479852 - A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder Phase 2
Recruiting NCT04032301 - Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans Phase 1
Recruiting NCT05527951 - Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study N/A
Completed NCT03511599 - Cycloserine rTMS Plasticity Augmentation in Depression Phase 1
Recruiting NCT04392947 - Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation N/A
Recruiting NCT05895747 - 5-HTP and Creatine for Depression R33 Phase Phase 2
Recruiting NCT05273996 - Predictors of Cognitive Outcomes in Geriatric Depression Phase 4
Recruiting NCT05813093 - Interleaved TMS-fMRI in Ultra-treatment Resistant Depression N/A
Recruiting NCT05135897 - The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
Enrolling by invitation NCT04509102 - Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder Early Phase 1
Recruiting NCT06026917 - Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET) Phase 4
Recruiting NCT06145594 - EMA-Guided Maintenance TMS for Depression N/A

External Links