Efficacy, Safety, and Tolerability of VLS-01-BU in Treatment Resistant Depression
Research type
Research Study
Full title
A Phase 2, Multicentre, Double-Blind, Randomised, Placebo-Controlled Trial to Assess the Efficacy, Safety, and Tolerability of Repeated Doses of VLS-01 Buccal Film in Participants with Treatment Resistant Depression.
IRAS ID
1012312
Contact name
Mary Shatzoff
Contact email
Sponsor organisation
atai Therapeutics Inc.
Clinicaltrials.gov Identifier
Research summary
This Phase 2 trial will determine the efficacy, safety, and tolerability of treatment with repeated doses of VLS-01 transmucosal buccal film (VLS-01-BU), which contains the active pharmaceutical ingredient and psychedelic N,N-dimethyltryptamine (DMT), in participants with treatment-resistant depression (TRD). The trial will also compare the onset and durability of antidepressant effects of VLS-01-BU versus placebo. The trial includes a 2-week placebo-controlled treatment period (Period 1), a 12-week placebo-controlled follow-up period (Period 2), and a 2-week non-placebo-controlled treatment and follow-up period (Period 3). Approximately 142 participants will be enrolled and randomised in a 1:1 ratio to receive a total of 2 placebo-controlled, double-blinded administrations of VLS-01-BU 120 mg or matching placebo, with a 2-week interval between each administration (Period 1). Participants will then be monitored for 12 weeks (Period 2) and then re-randomised in a 1:1 ratio to receive a third, double-blinded administration of VLS-01-BU 120 mg or VLS-01-BU 60 mg (Period 3). Participants will continute to be monitored for two weeks following this administration until the End of Study Visit (EOSV) for safety and to estimate the trajectory of their symptoms. VLS-01-BU (or placebo) will be delivered with standardised psychological support delivered by a trained healthcare provider. Trial participation will span up to 155 days and involve up to 17 visits, including a minimum of 9 in-clinic visits. Participants will complete various validated measures of symptoms and related functioning at each visit throughout the trial to help researchers understand the antidepressant effects, safety, and tolerability of VLS-01-BU in participants with TRD.
REC name
London - Riverside Research Ethics Committee
REC reference
25/LO/0408
Date of REC Opinion
5 Aug 2025
REC opinion
Further Information Favourable Opinion