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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
AXS-05 		AXS-05 tablets, taken twice daily
  • Drug: AXS-05
    Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period
Active Comparator
Bupropion 		Bupropion tablets, taken twice daily
  • Drug: Bupropion
    Up to 26 weeks in double-blind period

Recruiting Locations

Clinical Research Site
Bellflower, California 90706

Clinical Research Site
Lafayette, California 94549

Clinical Research Site
Oceanside, California 92056

Clinical Research Site
Redlands, California 92374

Clinical Research Site
Riverside, California 92506

Clinical Research Site
San Diego, California 92103

Clinical Research Site
Upland, California 91786

Clinical Research Site
Brandon, Florida 33511

Clinical Research Site
Doral, Florida 33122

Clinical Research Site
Hialeah, Florida 33012

Clinical Research Site
Jacksonville, Florida 32256

Clinical Research Site
Miami, Florida 33122

Clinical Research Site
Orlando, Florida 32801

Clinical Research Site
Orlando, Florida 32806

Clinical Research Site
Orlando, Florida 32807

Clinical Research Site
Atlanta, Georgia 30331

Clinical Research Site
Chicago, Illinois 60634

Clinical Research Site
Overland Park, Kansas 66210

Clinical Research Site
New Orleans, Louisiana 70115

Clinical Research Site
Boston, Massachusetts 02131

Clinical Research Site
Saint Charles, Missouri 63304

Clinical Research Site
Las Vegas, Nevada 89102

Clinical Research Site
Cherry Hill, New Jersey 08002

Clinical Research Site
Toms River, New Jersey 08755

Clinical Research Site
Brooklyn, New York 11235

Clinical Research Site
Mount Kisco, New York 10549

Clinical Research Site
New York, New York 10128

Clinical Research Site
Staten Island, New York 10314

Clinical Research Site
Hickory, North Carolina 28601

Clinical Research Site
Cincinnati, Ohio 45215

Clinical Research Site
Edmond, Oklahoma 73013

Clinical Research Site
Oklahoma City, Oklahoma 73118

Clinical Research Site
Portland, Oregon 97210

Clinical Research Site
Memphis, Tennessee 38119

Clinical Research Site
Dallas, Texas 75231

Clinical Research Site
Dallas, Texas 75243

Clinical Research Site
Friendswood, Texas 77546

Clinical Research Site
San Antonio, Texas 78229

Clinical Research Site
Wichita Falls, Texas 76309

Clinical Research Site
Everett, Washington 98201

More Details

Status
Recruiting
Sponsor
Axsome Therapeutics, Inc.

Study Contact

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

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.