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New buccal film could lift depression when other drugs fail

NCT ID NCT06524830

Symptom relief Sponsor: atai Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicated film placed inside the cheek (VLS-01) for people whose depression hasn't improved with at least two other treatments. About 142 adults aged 18-65 will receive either the film or a placebo to see if it safely eases depression symptoms. The goal is to find a faster-acting option for treatment-resistant depression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 142 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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.

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Conditions

The condition(s) this trial relates to.

Behavioral Symptoms Depression depressive disorder Depressive Disorder, Treatment-Resistant major depressive disorder mood disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment-resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    48 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Adams Clinical

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Aim Trials, LLC

    RECRUITING

    Plano, Texas, 75093, United States

  • Behavioral Research Specialists, LLC

    RECRUITING

    Glendale, California, 91206, United States

  • Bio Behavioral Health

    RECRUITING

    Toms River, New Jersey, 08755, United States

  • Biobehavioral Research of Austin

    RECRUITING

    Austin, Texas, 78759, United States

  • Bioresearch Partner

    RECRUITING

    Miami, Florida, 33155, United States

  • Cedar Clinical Research Inc

    RECRUITING

    Draper, Utah, 84020, United States

  • CenExcel

    RECRUITING

    Decatur, Georgia, 30030, United States

  • CenExel

    RECRUITING

    Garden Grove, California, 92845, United States

  • CenExel

    RECRUITING

    Hollywood, Florida, 33024, United States

  • CenExel

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Centre for Neurology Studies

    RECRUITING

    Surrey, British Columbia, V3V 0E8, Canada

  • Clerkenwell Health

    RECRUITING

    Doncaster, England, DN 4 8QN, United Kingdom

  • Clerkenwell Health

    RECRUITING

    London, England, W1U 6RP, United Kingdom

  • Clerkenwell Health

    RECRUITING

    London, W1G 8DR, United Kingdom

  • Clinilabs, LLC

    RECRUITING

    Eatontown, New Jersey, 07724, United States

  • Collaborative Neuroscience Research, LLC

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Elixia MA

    RECRUITING

    Springfield, Massachusetts, 01103, United States

  • InSite Clinical Research

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Institute for Integrative Therapies

    RECRUITING

    Eden Prairie, Minnesota, 55347, United States

  • Kadima Neuropsychiatry Institute

    RECRUITING

    La Jolla, California, 92037, United States

  • Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • Mountain View Clinical Research Inc.

    RECRUITING

    Denver, Colorado, 80209, United States

  • Neuro Behavioral Clinical Research, Inc.

    RECRUITING

    North Canton, Ohio, 44720, United States

  • NeuroCentrix

    RECRUITING

    Carlton, Victoria, 3053, Australia

  • NeuroClin

    RECRUITING

    Motherwell, England, ML1 4UF, United Kingdom

  • Noble Clinical Research

    RECRUITING

    Tucson, Arizona, 85704, United States

  • Paratus Clinical Research Melbourne

    RECRUITING

    Northcote, Victoria, 3070, Australia

  • Pillar Clinical Research LLC

    RECRUITING

    Chicago, Illinois, 60641, United States

  • Pillar Clinical Research, LLC

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Preferred Research Partners, Inc.

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Providence Care Hospital

    RECRUITING

    Kingston, Ontario, K7L 4X3, Canada

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Royal Melbourne Hospital Parkville

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Royal Prince Alfred Hospital

    RECRUITING

    Camperdown, New South Wales, NSW 2050, Australia

  • Scranton Medical Institute, LLC

    RECRUITING

    Moosic, Pennsylvania, 18507, United States

  • Seattle Neuropsychiatric Treatment Center

    RECRUITING

    Bellevue, Washington, 98004, United States

  • Sheppard Pratt

    RECRUITING

    Baltimore, Maryland, 21204, United States

  • Sunstone Medical, PC

    RECRUITING

    Rockville, Maryland, 20850, United States

  • Sydney Local Health District (SLHD) Mental Health

    RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • TRIP Clinical at Psychedelic Science Institute

    RECRUITING

    Santa Monica, California, 90404, United States

  • The Medical Research Network, LLC

    RECRUITING

    New York, New York, 10128, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Melbourne

    RECRUITING

    Carlton, Victoria, 3053, Australia

  • University of Melbourne

    RECRUITING

    Parkville, Victoria, 3052, Australia

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of South Florida, Psychiatry and Behavioral Neurosciences

    RECRUITING

    Tampa, Florida, 33613, United States

  • Woodland Research Northwest

    RECRUITING

    Rogers, Arkansas, 72758, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.