Recruiting
Phase 2

VLS-01

Sponsor:

atai Therapeutics, Inc.

Code:

NCT06524830

Conditions

Treatment Resistant Depression

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

VLS-01-203 BU

VLS-01-BU Placebo

Study Details

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

Study ID

NCT06524830

Start date

Dec 30, 2024

Status verified date

May, 2026

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: VLS-01-BU

placebo comparator: VLS-01-BU Placebo

Interventions

VLS-01-203 BU

VLS-01 buccal transmucosal administration

VLS-01-BU Placebo

Placebo buccal transmucosal administration

Primary outcome measure

  • Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score [ Time Frame: Baseline to Day 29 ]

Central Contacts and Locations

Central contacts

Kevin Craig, MD

332-282-0507clinicaltrials@atai.life

Locations

Noble Clinical Research

Recruiting

Tucson, Arizona, United States, 85704

Pillar Clinical Research, LLC

Recruiting

Little Rock, Arkansas, United States, 72204

Preferred Research Partners, Inc.

Recruiting

Little Rock, Arkansas, United States, 72211

Woodland Research Northwest

Recruiting

Rogers, Arkansas, United States, 72758

CenExel

Recruiting

Garden Grove, California, United States, 92845

Behavioral Research Specialists, LLC

Recruiting

Glendale, California, United States, 91206

Kadima Neuropsychiatry Institute

Recruiting

La Jolla, California, United States, 92037

Collaborative Neuroscience Research, LLC

Recruiting

Los Alamitos, California, United States, 90720

TRIP Clinical at Psychedelic Science Institute

Recruiting

Santa Monica, California, United States, 90404

Mountain View Clinical Research Inc.

Recruiting

Denver, Colorado, United States, 80209

CenExel

Recruiting

Hollywood, Florida, United States, 33024

Bioresearch Partner

Recruiting

Miami, Florida, United States, 33155

University of South Florida, Psychiatry and Behavioral Neurosciences

Recruiting

Tampa, Florida, United States, 33613

CenExcel

Recruiting

Decatur, Georgia, United States, 30030

CenExel

Recruiting

Savannah, Georgia, United States, 31405

Pillar Clinical Research LLC

Recruiting

Chicago, Illinois, United States, 60641

Sheppard Pratt

Recruiting

Baltimore, Maryland, United States, 21204

Sunstone Medical, PC

Recruiting

Rockville, Maryland, United States, 20850

Elixia MA

Recruiting

Springfield, Massachusetts, United States, 01103

Adams Clinical

Recruiting

Watertown, Massachusetts, United States, 02472

Institute for Integrative Therapies

Recruiting

Eden Prairie, Minnesota, United States, 55347

Midwest Research Group

Recruiting

Saint Charles, Missouri, United States, 63304

Clinilabs, LLC

Recruiting

Eatontown, New Jersey, United States, 07724

Bio Behavioral Health

Recruiting

Toms River, New Jersey, United States, 08755

The Medical Research Network, LLC

Recruiting

New York, New York, United States, 10128

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Neuro Behavioral Clinical Research, Inc.

Recruiting

North Canton, Ohio, United States, 44720

Scranton Medical Institute, LLC

Recruiting

Moosic, Pennsylvania, United States, 18507

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Biobehavioral Research of Austin

Recruiting

Austin, Texas, United States, 78759

InSite Clinical Research

Recruiting

DeSoto, Texas, United States, 75115

Aim Trials, LLC

Recruiting

Plano, Texas, United States, 75093

Cedar Clinical Research Inc

Recruiting

Draper, Utah, United States, 84020

Seattle Neuropsychiatric Treatment Center

Recruiting

Bellevue, Washington, United States, 98004

Centre for Neurology Studies

Recruiting

Surrey, British Columbia, Canada, V3V 0E8

Providence Care Hospital

Recruiting

Kingston, Ontario, Canada, K7L 4X3

More Information

Sponsor

atai Therapeutics, Inc.

Last update posted

May 11, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by atai Therapeutics, Inc. on 2026-05-11.