TerminatedPhase 2

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

Stopped: This study was terminated once overall program objectives were met.

United States181 participantsStarted 2020-09-23

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

What they're measuring

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

Timeframe: 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.

Trial details

NCT IDNCT04634669

SponsorAxsome Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-18

Results submitted2025-03-03

View on ClinicalTrials.gov More Treatment Resistant Depression trials