NCT04634669Phase 2Terminated

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

Study sponsor: Axsome Therapeutics, Inc. · AXSM

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-02-18Actual

Enrollment · participants181Actual

Source updated2026-01-28Last update listed in the registry record

Version history

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Posted 2026-01-28 · 1 field changed

Recruitment status

Recorded edit

− Previous value

Completed

+ Updated value

Terminated

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Study details

Conditions studied

Treatment Resistant Depression; Major Depressive Disorder

Treatments or interventions studied

AXS-05 (dextromethorphan-bupropion)Drug

Primary outcomes · main study measures

measure: 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.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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