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

Phase 2 Recruiting 142 enrolled atai Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2024-12-30
Primary completion: 2026-08-01
Completion: 2026-08-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dimethyltryptamine	Unknown	—	Other

Indications

No indication recorded.