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

Axsome Therapeutics

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Treatment Resistant Depression

Treatments: Drug: AXS-05 (dextromethorphan-bupropion)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04634669

AXS-05-TRD-202

Details and patient eligibility

About

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).

Full 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.

Enrollment: 186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features
• Continued depression despite treatment with antidepressants in the current depressive episode
• Agree to use adequate method of contraception for the duration of the study
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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186 participants in 1 patient group

AXS-05 (dextromethorphan-bupropion)

Experimental group

Treatment:

Drug: AXS-05 (dextromethorphan-bupropion)