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

Keywords

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