Who is eligible for clinical trial NCT06524830?

Participants must meet protocol criteria for Treatment Resistant Depression. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06524830 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-08

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 Phase2 💊 Investigational Drug / Biologic Sponsor: atai Therapeutics, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (11 items).

Location: Noble Clinical Research — Tucson, Arizona

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (48 Sites)

Noble Clinical Research — Tucson, Arizona
Pillar Clinical Research, LLC — Little Rock, Arkansas
Preferred Research Partners, Inc. — Little Rock, Arkansas
Woodland Research Northwest — Rogers, Arkansas
CenExel — Garden Grove, California
Behavioral Research Specialists, LLC — Glendale, California
Kadima Neuropsychiatry Institute — La Jolla, California
Collaborative Neuroscience Research, LLC — Los Alamitos, California
TRIP Clinical at Psychedelic Science Institute — Santa Monica, California
Mountain View Clinical Research Inc. — Denver, Colorado
CenExel — Hollywood, Florida
Bioresearch Partner — Miami, Florida
University of South Florida, Psychiatry and Behavioral Neurosciences — Tampa, Florida
CenExcel — Decatur, Georgia
CenExel — Savannah, Georgia
Pillar Clinical Research LLC — Chicago, Illinois
Sheppard Pratt — Baltimore, Maryland
Sunstone Medical, PC — Rockville, Maryland
Elixia MA — Springfield, Massachusetts
Adams Clinical — Watertown, Massachusetts
Institute for Integrative Therapies — Eden Prairie, Minnesota
Midwest Research Group — Saint Charles, Missouri
Clinilabs, LLC — Eatontown, New Jersey
Bio Behavioral Health — Toms River, New Jersey
The Medical Research Network, LLC — New York, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗