Status: Recruiting
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
Participants needed: 142
Trial details
Phase: Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: atai Therapeutics, Inc.Updated: May 11, 2026Locations: 48
Eligibility criteria
Participant must be 18 to 65 years of age inclusive at the time of signing the I... [+4]
Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other... [+9]