NCT06223880 · Axsome Therapeutics, Inc.
A Study to Evaluate the Efficacy of AXS-05 Compared to Bupropion in Preventing the Relapse of Depressive Symptoms
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, active-controlled, multi-center study to evaluate the effectiveness 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.
View original scientific description
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.
Interventions
DRUG
AXS-05
Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period
DRUG
Bupropion
Up to 26 weeks in double-blind period
Primary outcome measures
Time from randomization to relapse of depressive symptoms
Time frame: up to 26 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bellflower, California
- Lafayette, California
- Oceanside, California
- Redlands, California
- Riverside, California
- San Diego, California
- Upland, California
- Brandon, Florida
- Doral, Florida
- Hialeah, Florida
- Jacksonville, Florida
- Miami, Florida
And 25 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2025 · Source of record for eligibility and locations