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

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

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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