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

Conditions

• Major Depressive Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Dec 27, 2023

Status verified

Jan 2025

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: AXS-05
  AXS-05 tablets, taken twice daily
• Active Comparator: Bupropion
  Bupropion tablets, taken twice daily

Primary Outcome Measure

Time from randomization to relapse of depressive symptoms [ Time Frame: up to 26 weeks ]

Central Contacts

• Study Director
  +1 (212) 332-5061
  [email protected]

Locations (40)

Find similar trials in Bellflower, CA

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