Recruiting

AXS-05 vs. Bupropion

Sponsor:

Axsome Therapeutics, Inc.

Code:

NCT06223880

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

AXS-05

Bupropion

Study Details

Brief 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.

Conditions

Major Depressive Disorder

Study ID

NCT06223880

Start date

Dec 27, 2023

Status verified date

Jan, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AXS-05

AXS-05 tablets, taken twice daily

active comparator: Bupropion

Bupropion tablets, taken twice daily

Interventions

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

Primary outcome measure

  • Time from randomization to relapse of depressive symptoms [ Time Frame: up to 26 weeks ]

Central Contacts and Locations

Central contacts

Study Director

+1 (212) 332-5061axs-05-mdd-401@axsome.com

Locations

Clinical Research Site

Recruiting

Bellflower, California, United States, 90706

Clinical Research Site

Recruiting

Lafayette, California, United States, 94549

Clinical Research Site

Recruiting

Oceanside, California, United States, 92056

Clinical Research Site

Recruiting

Redlands, California, United States, 92374

Clinical Research Site

Recruiting

Riverside, California, United States, 92506

Clinical Research Site

Recruiting

San Diego, California, United States, 92103

Clinical Research Site

Recruiting

Upland, California, United States, 91786

Clinical Research Site

Recruiting

Brandon, Florida, United States, 33511

Clinical Research Site

Recruiting

Doral, Florida, United States, 33122

Clinical Research Site

Recruiting

Hialeah, Florida, United States, 33012

Clinical Research Site

Recruiting

Jacksonville, Florida, United States, 32256

Clinical Research Site

Recruiting

Miami, Florida, United States, 33122

Clinical Research Site

Recruiting

Orlando, Florida, United States, 32801

Clinical Research Site

Recruiting

Orlando, Florida, United States, 32806

Clinical Research Site

Recruiting

Orlando, Florida, United States, 32807

Clinical Research Site

Recruiting

Atlanta, Georgia, United States, 30331

Clinical Research Site

Recruiting

Chicago, Illinois, United States, 60634

Clinical Research Site

Recruiting

Overland Park, Kansas, United States, 66210

Clinical Research Site

Recruiting

New Orleans, Louisiana, United States, 70115

Clinical Research Site

Recruiting

Boston, Massachusetts, United States, 02131

Clinical Research Site

Recruiting

Saint Charles, Missouri, United States, 63304

Clinical Research Site

Recruiting

Las Vegas, Nevada, United States, 89102

Clinical Research Site

Recruiting

Cherry Hill, New Jersey, United States, 08002

Clinical Research Site

Recruiting

Toms River, New Jersey, United States, 08755

Clinical Research Site

Recruiting

Brooklyn, New York, United States, 11235

Clinical Research Site

Recruiting

Mount Kisco, New York, United States, 10549

Clinical Research Site

Recruiting

New York, New York, United States, 10128

Clinical Research Site

Recruiting

Staten Island, New York, United States, 10314

Clinical Research Site

Recruiting

Hickory, North Carolina, United States, 28601

Clinical Research Site

Recruiting

Cincinnati, Ohio, United States, 45215

Clinical Research Site

Recruiting

Edmond, Oklahoma, United States, 73013

Clinical Research Site

Recruiting

Oklahoma City, Oklahoma, United States, 73118

Clinical Research Site

Recruiting

Portland, Oregon, United States, 97210

Clinical Research Site

Recruiting

Memphis, Tennessee, United States, 38119

Clinical Research Site

Recruiting

Dallas, Texas, United States, 75231

Clinical Research Site

Recruiting

Dallas, Texas, United States, 75243

Clinical Research Site

Recruiting

Friendswood, Texas, United States, 77546

Clinical Research Site

Recruiting

San Antonio, Texas, United States, 78229

Clinical Research Site

Recruiting

Wichita Falls, Texas, United States, 76309

Clinical Research Site

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

Axsome Therapeutics, Inc.

Last update posted

Jan 23, 2025

Last verified

Jan, 2025

Keywords

  • AXS-05
  • Dextromethorphan
  • Bupropion
  • MDD
  • Depression
  • Relapse of depressive symptoms
  • NMDA receptor antagonist
  • Sigma-1 receptor agonist
  • Norepinephrine reuptake inhibitor
  • Dopamine reuptake inhibitor
  • Axsome Therapeutics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Axsome Therapeutics, Inc. on 2025-01-23.