Health TrialsbyHealthPanel

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

ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAxsome Therapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Currently meets DSM-5 criteria for diagnosis of MDD without psychotic features

Current major depressive episode of at least 4 weeks in duration

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • AXS-05

    Drug

    Up to 10 weeks in open-label period; Up to 26 weeks in double-blind period

  • Bupropion

    Drug

    Up to 26 weeks in double-blind period

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: AXS-05Experimental treatment 1 intervention
Group B: BupropionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time from randomization to relapse of depressive symptoms

Time frame
up to 26 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Axsome Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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