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RecruitingPhase 4

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 26 weeks
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares AXS-05 with bupropion to see which better keeps depression symptoms from coming back. It is for people with major depressive disorder whose symptoms improved with AXS-05 treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a current diagnosis of major depressive disorder without psychotic symptoms, such as seeing or hearing things that are not there.
  • Have had the current period of depression for at least 4 weeks.

Who can't join

  • Have taken part in another study of AXS-05.
  • Received an experimental drug or device treatment within 30 days before the first screening visit.
  • Have been prescribed Auvelity.
  • Cannot follow the study steps.
  • The study doctor believes taking part is not medically appropriate for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (40)

CA

FL

GA

IL

KS

LA

MA

MO

NC

NJ

NV

NY

OH

OK

OR

TN

TX

WA