RecruitingPhase 2NCT06524830

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

Sponsor

atai Therapeutics, Inc.

Enrollment

142 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

Treatment Resistant Depression

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment for treatment-resistant depression called VLS-01, which is delivered as a dissolvable film placed inside the cheek. VLS-01 contains a compound being studied for its potential antidepressant effects. It is being compared to a placebo in people whose depression has not improved after trying multiple antidepressant medications. **You may be eligible if...** - You are between 18 and 65 years old - You have a diagnosis of moderate or severe major depressive disorder (MDD) and are currently experiencing a depressive episode - Your first episode of depression occurred before age 55 - You have tried at least 2 but no more than 5 antidepressant medications without adequate improvement during your current episode **You may NOT be eligible if...** - You have schizophrenia, bipolar disorder, or a history of psychosis - You have a moderate or severe substance use disorder in the past 6–12 months - You have had suicidal thoughts with intent to act in the past 6 months - You have significant heart, blood vessel, or circulation problems - You have an active or recent cancer - You have started a new type of talk therapy in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVLS-01-203 BU

VLS-01 buccal transmucosal administration

DRUGVLS-01-BU Placebo

Placebo buccal transmucosal administration

Locations(42)

Noble Clinical Research

Tucson, Arizona, United States

Pillar Clinical Research, LLC

Little Rock, Arkansas, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

CenExel

Garden Grove, California, United States

Behavioral Research Specialists, LLC

Glendale, California, United States

Kadima Neuropsychiatry Institute

La Jolla, California, United States

TRIP Clinical at Psychedelic Science Institute

Santa Monica, California, United States

Mountain View Clinical Research Inc.

Denver, Colorado, United States

CenExel

Hollywood, Florida, United States

Bioresearch Partner

Miami, Florida, United States

University of South Florida, Psychiatry and Behavioral Neurosciences

Tampa, Florida, United States

CenExcel

Decatur, Georgia, United States

CenExel

Savannah, Georgia, United States

Pillar Clinical Research LLC

Chicago, Illinois, United States

Sunstone Medical, PC

Rockville, Maryland, United States

Elixia MA

Springfield, Massachusetts, United States

Adams Clinical

Watertown, Massachusetts, United States

Institute for Integrative Therapies

Eden Prairie, Minnesota, United States

Midwest Research Group

Saint Charles, Missouri, United States

Clinilabs, LLC

Eatontown, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

The Medical Research Network, LLC

New York, New York, United States

The Ohio State University

Columbus, Ohio, United States

Neuro Behavioral Clinical Research, Inc.

North Canton, Ohio, United States

Scranton Medical Institute, LLC

Moosic, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Biobehavioral Research of Austin

Austin, Texas, United States

InSite Clinical Research

DeSoto, Texas, United States

Aim Trials, LLC

Plano, Texas, United States

Cedar Clinical Research Inc

Draper, Utah, United States

Seattle Neuropsychiatric Treatment Center

Bellevue, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

NeuroCentrix

Carlton, Victoria, Australia

Paratus Clinical Research Melbourne

Northcote, Victoria, Australia

University of Melbourne

Parkville, Victoria, Australia

Centre for Neurology Studies

Surrey, British Columbia, Canada

Providence Care Hospital

Kingston, Ontario, Canada

Clerkenwell Health

Doncaster, England, United Kingdom

Clerkenwell Health

London, England, United Kingdom

NeuroClin

Motherwell, England, United Kingdom

Clerkenwell Health

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06524830

Related Trials

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(42)

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