Mechanistic Evaluation of Response in TRD (MERIT)

Axsome Therapeutics

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Treatments: Drug: Placebo; Drug: AXS-05

Study type: Interventional

Funder types: Industry

Identifiers

NCT04608396

AXS-05-TRD-201

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

AXS-05

Experimental group

Treatment:

Drug: AXS-05

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo