Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE)

Phase 2

Completed

• Conditions: Treatment Resistant Depression; Major Depressive Disorder
• Interventions: Drug: AXS-05 (dextromethorphan-bupropion)

• Registration Number: NCT04634669
• Lead Sponsor: Axsome Therapeutics, Inc.

Brief Summary

This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with treatment resistant depression (TRD) and major depressive disorder (MDD).

Detailed Description

Eligible subjects must have either completed Study AXS-05-TRD-201 immediately prior to enrollment in this study or meet the DSM-5 criteria for major depressive disorder (MDD) without psychotic features.

Study Timeline

• Study Start: 2020-09-23
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-18
• Primary Completion: 2022-03-04
• Study Completion: 2022-03-04
• Status Verified: 2023-03
• Disposition First Submitted: 2023-03-03
• Last Update Submitted: 2023-03-03
• Disposition First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AXS-05 (dextromethorphan-bupropion)	AXS-05 (dextromethorphan-bupropion)	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent AEs (TEAEs) following dosing with AXS-05	Up to 15 months

Trial Locations

Locations (1)

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