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 December 22, 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

ClinConnect Summary

This clinical trial is studying a medication called AXS-05 to see how well it works in preventing a return of depressive symptoms in adults who have major depressive disorder (MDD) and have already had a positive response to AXS-05 treatment. The trial is comparing AXS-05 to another medication called bupropion. Participants in the study will be randomly assigned to receive either AXS-05 or bupropion, and neither they nor the researchers will know which medication they are receiving, which helps ensure unbiased results.

To be eligible for this trial, you must be between the ages of 65 and 74 or 23 and 740, currently diagnosed with MDD without any other serious mental health issues, and have been experiencing major depressive symptoms for at least four weeks. Participants will be monitored throughout the study, and those who join can expect regular check-ins and support from the research team. It’s important to note that if you have previously participated in a study involving AXS-05 or have taken certain medications recently, you may not qualify for this trial. Overall, this study aims to find better ways to help people manage their depression and improve their quality of life.

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 Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for central nervous system (CNS) disorders. With a commitment to addressing unmet medical needs, Axsome leverages its proprietary drug development platform to advance a diverse pipeline of product candidates targeting conditions such as depression, migraine, and insomnia. The company is dedicated to improving patient outcomes through rigorous clinical research and collaboration with healthcare professionals, aiming to transform the treatment landscape for patients suffering from debilitating neurological and psychiatric conditions.

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