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

Phase 2TerminatedNCT04634669

Axsome Therapeutics, Inc.181 enrolled

Overview

This study is a multi-center, open-label trial to evaluate the long-term safety and efficacy of AXS-05 in subjects with major depressive disorder with prior treatment failures

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

181

Conditions

Treatment Resistant Depression Major Depressive Disorder

Interventions

AXS-05 (dextromethorphan-bupropion)DRUG

\- Titrated to AXS-05 (45 mg dextromethorphan HBr / 105 mg bupropion HCl) twice daily (up to 15 months)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* Completed Study AXS-05-TRD-201 OR currently meets the DSM-5 criteria for MDD without psychotic features and with prior antidepressant treatment failure * 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

Incidence of Treatment-emergent AEs (TEAEs) Following Dosing With AXS-05

Time frame: Duration of participation was up to 15 months. TEAEs were defined as any AE with an onset date in the interval between the first study treatment dosing date and 7 days after the last study treatment dosing date.

Data from ClinicalTrials.gov

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