Search / Trial NCT06223880

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

Launched by AXSOME THERAPEUTICS, INC. · Jan 16, 2024

Trial Information

Current as of October 03, 2024

Recruiting

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

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.

Gender

ALL

Eligibility criteria

  • 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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

San Antonio, Texas, United States

Bellflower, California, United States

Upland, California, United States

New Orleans, Louisiana, United States

Dallas, Texas, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

Redlands, California, United States

San Diego, California, United States

Hialeah, Florida, United States

Atlanta, Georgia, United States

Boston, Massachusetts, United States

Las Vegas, Nevada, United States

Toms River, New Jersey, United States

Memphis, Tennessee, United States

Lafayette, California, United States

Oceanside, California, United States

Riverside, California, United States

Miami, Florida, United States

Edmond, Oklahoma, United States

Everett, Washington, United States

Chicago, Illinois, United States

Cherry Hill, New Jersey, United States

Hickory, North Carolina, United States

Wichita Falls, Texas, United States

Cincinnati, Ohio, United States

Brandon, Florida, United States

Doral, Florida, United States

Overland Park, Kansas, United States

Saint Charles, Missouri, United States

Mount Kisco, New York, United States

New York, New York, United States

Oklahoma City, Oklahoma, United States

Brooklyn, New York, United States

Portland, Oregon, United States

Staten Island, New York, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0