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

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Axsome Therapeutics

Status and phase

Enrolling
Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Bupropion
Drug: AXS-05

Study type

Interventional

Funder types

Industry

Identifiers

NCT06223880
AXS-05-MDD-401

Details and patient eligibility

About

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.

Full 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.

Enrollment

350 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

350 participants in 2 patient groups

AXS-05
Experimental group
Description:
AXS-05 tablets, taken twice daily
Treatment:
Drug: AXS-05
Bupropion
Active Comparator group
Description:
Bupropion tablets, taken twice daily
Treatment:
Drug: Bupropion

Trial contacts and locations

39

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Central trial contact

Study Director

Data sourced from clinicaltrials.gov

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