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

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Treatment Resistant Depression

Eligibility basics and study details

Study type

Interventional

Phase

Phase 2

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

atai Therapeutics, Inc.

Last updated on ClinicalTrials.gov

May 11, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites