NCT06524830

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)

A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of Repeated Doses of VLS-01 Buccal Film in Participants With Treatment Resistant Depression

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: atai Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial will enroll approximately 142 participants with TRD, randomized 1:1 to receive a total of 2 double-blind administrations of VLS- 01-BU (buccal film containing VLS-01) or placebo, administered via the buccal transmucosal route, with a 2-week interval between each administration, during the placebo-controlled treatment period. All participants will have their symptoms monitored for 12 weeks in the placebo- controlled follow-up period, following the second administration of VLS-01-BU or placebo. After the placebo-controlled treatment and observation period all participants will be re-randomized 1:1 to receive one double-blinded administration of VLS-01-BU (dose strength 1 or dose strength 2) during a non-placebo-controlled treatment period. Final safety and efficacy assessment will be conducted two weeks after administration of the third dose.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	VLS-01-203 BU	VLS-01 buccal transmucosal administration
DRUG	VLS-01-BU Placebo	Placebo buccal transmucosal administration

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-03-01
• Completion: 2026-03-30
• First posted: 2024-07-29
• Last updated: 2026-02-04

Locations

42 sites across 4 countries: United States, Australia, Canada, United Kingdom

Regulatory

• FDA-regulated drug study