Mechanistic Evaluation of Response in TRD (MERIT)

Phase 2

Completed

• Conditions: Treatment Resistant Depression; Major Depressive Disorder
• Interventions: Drug: AXS-05; Drug: Placebo

• Registration Number: NCT04608396
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-13
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-10-29
• Primary Completion: 2021-07-30
• Study Completion: 2021-07-30
• Status Verified: 2022-07
• Disposition First Submitted: 2022-07-08
• Disposition First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Disposition First Posted: 2022-07-12
• Last Update Posted: 2022-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AXS-05	AXS-05	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Relapse	Time from randomization to first relapse (up to 52 weeks)	Assessed by clinician-rated scales.

Trial Locations

Locations (1)

Clinical Research Site; 🇺🇸 Everett, Washington, United States