Mechanistic Evaluation of Response in TRD (MERIT)

Axsome Therapeutics, Inc.44 enrolled

Overview

To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD). This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Treatment Resistant Depression Major Depressive Disorder

Interventions

AXS-05DRUG

AXS-05 taken daily for up to 52 weeks, until relapse.

PlaceboDRUG

Placebo taken daily for up to 52 weeks, until relapse.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Eligibility Criteria: * Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05 * Agree to use adequate method of contraception for the duration of the study * Additional criteria may apply

Locations (20)

Clinical Research Site

Little Rock, Arkansas, United States

Clinical Research Site

Redlands, California, United States

Outcomes

Primary Outcomes

Relapse

Assessed by clinician-rated scales.

Time frame: Time from randomization to first relapse (up to 52 weeks)

Data from ClinicalTrials.gov

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