RecruitingPhase 4NCT06223880

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

A Randomized, Double-blind, Active-controlled Study of AXS-05 for the Prevention of Relapse of Depressive Symptoms


Sponsor

Axsome Therapeutics, Inc.

Enrollment

350 participants

Start Date

Dec 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments — AXS-05 (a combination drug with dextromethorphan and bupropion) and bupropion alone — to see which is better at preventing depression from coming back in people who currently have major depressive disorder (MDD). **You may be eligible if...** - You have been diagnosed with major depressive disorder (MDD) without psychosis - You are currently in a major depressive episode lasting at least 4 weeks - You are able to comply with study procedures **You may NOT be eligible if...** - You have previously participated in an AXS-05 clinical study or have been prescribed Auvelity (the brand name of AXS-05) - You received another investigational drug within 30 days of your screening visit - Your doctor does not consider participation medically appropriate for you Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAXS-05

Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period

DRUGBupropion

Up to 26 weeks in double-blind period


Locations(40)

Clinical Research Site

Bellflower, California, United States

Clinical Research Site

Lafayette, California, United States

Clinical Research Site

Oceanside, California, United States

Clinical Research Site

Redlands, California, United States

Clinical Research Site

Riverside, California, United States

Clinical Research Site

San Diego, California, United States

Clinical Research Site

Upland, California, United States

Clinical Research Site

Brandon, Florida, United States

Clinical Research Site

Doral, Florida, United States

Clinical Research Site

Hialeah, Florida, United States

Clinical Research Site

Jacksonville, Florida, United States

Clinical Research Site

Miami, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Orlando, Florida, United States

Clinical Research Site

Atlanta, Georgia, United States

Clinical Research Site

Chicago, Illinois, United States

Clinical Research Site

Overland Park, Kansas, United States

Clinical Research Site

New Orleans, Louisiana, United States

Clinical Research Site

Boston, Massachusetts, United States

Clinical Research Site

Saint Charles, Missouri, United States

Clinical Research Site

Las Vegas, Nevada, United States

Clinical Research Site

Cherry Hill, New Jersey, United States

Clinical Research Site

Toms River, New Jersey, United States

Clinical Research Site

Brooklyn, New York, United States

Clinical Research Site

Mount Kisco, New York, United States

Clinical Research Site

New York, New York, United States

Clinical Research Site

Staten Island, New York, United States

Clinical Research Site

Hickory, North Carolina, United States

Clinical Research Site

Cincinnati, Ohio, United States

Clinical Research Site

Edmond, Oklahoma, United States

Clinical Research Site

Oklahoma City, Oklahoma, United States

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Portland, Oregon, United States

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Memphis, Tennessee, United States

Clinical Research Site

Dallas, Texas, United States

Clinical Research Site

Dallas, Texas, United States

Clinical Research Site

Friendswood, Texas, United States

Clinical Research Site

San Antonio, Texas, United States

Clinical Research Site

Wichita Falls, Texas, United States

Clinical Research Site

Everett, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06223880


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