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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06223880

Enrollment

350

Registered

2024-01-25

Start date

2023-12-27

Completion date

2026-03-31

Last updated

2025-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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

Brief 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.

Detailed description

Eligible subjects will receive open-label AXS-05 during the 10-week open-label treatment period, during which they will be monitored for response and remission. 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time from randomization to relapse of depressive symptoms	up to 26 weeks

Countries

United States

Contacts

Primary ContactStudy Director

axs-05-mdd-401@axsome.com+1 (212) 332-5061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026