A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
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
- Major Depressive Disorder
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental AXS-05 |
AXS-05 tablets, taken twice daily |
|
|
Active Comparator Bupropion |
Bupropion tablets, taken twice daily |
|
Recruiting Locations
Clinical Research Site
Bellflower, California 90706
Bellflower, California 90706
Clinical Research Site
Lafayette, California 94549
Lafayette, California 94549
Clinical Research Site
Oceanside, California 92056
Oceanside, California 92056
Clinical Research Site
Redlands, California 92374
Redlands, California 92374
Clinical Research Site
Riverside, California 92506
Riverside, California 92506
Clinical Research Site
San Diego, California 92103
San Diego, California 92103
Clinical Research Site
Upland, California 91786
Upland, California 91786
Clinical Research Site
Brandon, Florida 33511
Brandon, Florida 33511
Clinical Research Site
Doral, Florida 33122
Doral, Florida 33122
Clinical Research Site
Hialeah, Florida 33012
Hialeah, Florida 33012
Clinical Research Site
Jacksonville, Florida 32256
Jacksonville, Florida 32256
Clinical Research Site
Miami, Florida 33122
Miami, Florida 33122
Clinical Research Site
Orlando, Florida 32801
Orlando, Florida 32801
Clinical Research Site
Orlando, Florida 32806
Orlando, Florida 32806
Clinical Research Site
Orlando, Florida 32807
Orlando, Florida 32807
Clinical Research Site
Atlanta, Georgia 30331
Atlanta, Georgia 30331
Clinical Research Site
Chicago, Illinois 60634
Chicago, Illinois 60634
Clinical Research Site
Overland Park, Kansas 66210
Overland Park, Kansas 66210
Clinical Research Site
New Orleans, Louisiana 70115
New Orleans, Louisiana 70115
Clinical Research Site
Boston, Massachusetts 02131
Boston, Massachusetts 02131
Clinical Research Site
Saint Charles, Missouri 63304
Saint Charles, Missouri 63304
Clinical Research Site
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Clinical Research Site
Cherry Hill, New Jersey 08002
Cherry Hill, New Jersey 08002
Clinical Research Site
Toms River, New Jersey 08755
Toms River, New Jersey 08755
Clinical Research Site
Brooklyn, New York 11235
Brooklyn, New York 11235
Clinical Research Site
Mount Kisco, New York 10549
Mount Kisco, New York 10549
Clinical Research Site
New York, New York 10128
New York, New York 10128
Clinical Research Site
Staten Island, New York 10314
Staten Island, New York 10314
Clinical Research Site
Hickory, North Carolina 28601
Hickory, North Carolina 28601
Clinical Research Site
Cincinnati, Ohio 45215
Cincinnati, Ohio 45215
Clinical Research Site
Edmond, Oklahoma 73013
Edmond, Oklahoma 73013
Clinical Research Site
Oklahoma City, Oklahoma 73118
Oklahoma City, Oklahoma 73118
Clinical Research Site
Portland, Oregon 97210
Portland, Oregon 97210
Clinical Research Site
Memphis, Tennessee 38119
Memphis, Tennessee 38119
Clinical Research Site
Dallas, Texas 75231
Dallas, Texas 75231
Clinical Research Site
Dallas, Texas 75243
Dallas, Texas 75243
Clinical Research Site
Friendswood, Texas 77546
Friendswood, Texas 77546
Clinical Research Site
San Antonio, Texas 78229
San Antonio, Texas 78229
Clinical Research Site
Wichita Falls, Texas 76309
Wichita Falls, Texas 76309
Clinical Research Site
Everett, Washington 98201
Everett, Washington 98201
More Details
- Status
- Recruiting
- Sponsor
- Axsome Therapeutics, Inc.
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.