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

NCT06524830 | Recruiting Phase 2 FDA Drug

• 1 other identifier: VLS-01-203
• Study Type: interventional
• Target: 142
• Locations: 4 countries
• Sites: 48

Brief 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.

Conditions

Treatment Resistant Depression

Keywords

Major Depression; Mood Disorders; Mental Disorders; Depressive Disorder; Depression; Depressive Disorder, Major; Antidepressive Agents; Psychotropic Drugs; Treatment Resistant Depression; Behavioral Symptoms; Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score

  Baseline to Day 29

Secondary Outcomes (1)

• Change from Baseline in MADRS total score

  Baseline to Day 43

Other Outcomes (3)

• Incidence and severity of adverse events, adverse events of special interest and serious adverse events

  Baseline to Day 113

• Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results

  Baseline to Day 113

• Columbia-Suicide Severity Rating Scale (C- SSRS) scores

  Baseline to Day 113

Study Arms (2)

VLS-01-BU

EXPERIMENTAL

Drug: VLS-01-203 BU

VLS-01-BU Placebo

PLACEBO COMPARATOR

Drug: VLS-01-BU Placebo

Interventions

VLS-01-203 BU DRUG

VLS-01 buccal transmucosal administration

VLS-01-BU

VLS-01-BU Placebo DRUG

Placebo buccal transmucosal administration

VLS-01-BU Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be 18 to 65 years of age inclusive at the time of signing the Informed Consent.
• Has a diagnosis of recurrent moderate or severe MDD without psychotic features or single- episode MDD with duration greater than or equal to 3 months without psychotic features and is currently experiencing a major depressive episode.
• Onset of first episode of MDD occurred before age 55.
• Has not responded to an adequate dose and duration of at least two and no more than five antidepressant medications for the current depressive episode, as determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH- ATRQ).
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

You may not qualify if:

• Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other psychotic disorder, substance/medication-induced psychotic disorder, bipolar and related disorder, or any disorder with psychotic features.
• Has a moderate or severe substance use disorder (drug, alcohol, or tobacco) within the 6 months before Screening and/or history of moderate or severe substance use disorder (drug alcohol) within the previous 1 year before Screening
• Has a history of, or current signs and symptoms of, diseases or conditions that would make participation not be in the best interest (e.g., compromise the wellbeing) of the participant or that could prevent, limit, or confound the protocol-specified assessments.
• Has suicidal ideation with some intent to act within 6 months before Screening or a history of suicidal behavior within the past 1 year before Screening.
• Has a history of clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease or condition, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, valvular heart disease, obstructive coronary artery disease, hypertension, hypotension, bradycardia, tachycardia, or risk factors for long QT Syndrome.
• Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before Screening.
• Has any known allergy or hypersensitivity to VLS-01 or to any of the excipients in the formulation.
• Has recently initiated and is currently undergoing directive psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy) within the past 30 days before Screening. Participants planning to initiate individual or group therapy during the study are also not eligible.
• Has received any prohibited therapies.
• Has clinically significant laboratory abnormalities at Screening.

Sponsors & Collaborators

• atai Therapeutics, Inc.: lead

Study Sites (48)

Noble Clinical Research

Tucson, Arizona, 85704, United States

RECRUITING

Pillar Clinical Research, LLC

Little Rock, Arkansas, 72204, United States

RECRUITING

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

RECRUITING

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

RECRUITING

CenExel

Garden Grove, California, 92845, United States

RECRUITING

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

RECRUITING

Kadima Neuropsychiatry Institute

La Jolla, California, 92037, United States

RECRUITING

Collaborative Neuroscience Research, LLC

Los Alamitos, California, 90720, United States

RECRUITING

TRIP Clinical at Psychedelic Science Institute

Santa Monica, California, 90404, United States

RECRUITING

Mountain View Clinical Research Inc.

Denver, Colorado, 80209, United States

RECRUITING

CenExel

Hollywood, Florida, 33024, United States

RECRUITING

Bioresearch Partner

Miami, Florida, 33155, United States

RECRUITING

University of South Florida, Psychiatry and Behavioral Neurosciences

Tampa, Florida, 33613, United States

RECRUITING

CenExcel

Decatur, Georgia, 30030, United States

RECRUITING

CenExel

Savannah, Georgia, 31405, United States

RECRUITING

Pillar Clinical Research LLC

Chicago, Illinois, 60641, United States

RECRUITING

Sunstone Medical, PC

Rockville, Maryland, 20850, United States

RECRUITING

Elixia MA

Springfield, Massachusetts, 01103, United States

RECRUITING

Adams Clinical

Watertown, Massachusetts, 02472, United States

RECRUITING

Institute for Integrative Therapies

Eden Prairie, Minnesota, 55347, United States

RECRUITING

Midwest Research Group

Saint Charles, Missouri, 63304, United States

RECRUITING

Clinilabs, LLC

Eatontown, New Jersey, 07724, United States

RECRUITING

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

RECRUITING

The Medical Research Network, LLC

New York, New York, 10128, United States

RECRUITING

ACM Global Laboratories

Rochester, New York, 14624, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Neuro Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

RECRUITING

Scranton Medical Institute, LLC

Moosic, Pennsylvania, 18507, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biobehavioral Research of Austin

Austin, Texas, 78759, United States

RECRUITING

InSite Clinical Research

DeSoto, Texas, 75115, United States

RECRUITING

Aim Trials, LLC

Plano, Texas, 75093, United States

RECRUITING

Cedar Clinical Research Inc

Draper, Utah, 84020, United States

RECRUITING

Seattle Neuropsychiatric Treatment Center

Bellevue, Washington, 98004, United States

RECRUITING

Sydney Local Health District (SLHD) Mental Health

Camperdown, New South Wales, 2050, Australia

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, NSW 2050, Australia

RECRUITING

NeuroCentrix

Carlton, Victoria, 3053, Australia

RECRUITING

The University of Melbourne

Carlton, Victoria, 3053, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, 3000, Australia

RECRUITING

Paratus Clinical Research Melbourne

Northcote, Victoria, 3070, Australia

RECRUITING

Royal Melbourne Hospital Parkville

Parkville, Victoria, 3050, Australia

RECRUITING

University of Melbourne

Parkville, Victoria, 3052, Australia

RECRUITING

Centre for Neurology Studies

Surrey, British Columbia, V3V 0E8, Canada

RECRUITING

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

RECRUITING

Clerkenwell Health

Doncaster, England, DN 4 8QN, United Kingdom

RECRUITING

Clerkenwell Health

London, England, W1U 6RP, United Kingdom

RECRUITING

NeuroClin

Motherwell, England, ML1 4UF, United Kingdom

RECRUITING

Clerkenwell Health

London, W1G 8DR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Depressive Disorder; Depression; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Kevin Craig, MD

CONTACT

332-282-0507; clinicaltrials@atai.life

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (34); GB (4); CA (2); AU (8)