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

May 8, 2026 updated by: atai Therapeutics, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial will enroll approximately 142 participants with TRD, randomized 1:1 to receive a total of 2 double-blind administrations of VLS- 01-BU (buccal film containing VLS-01) or placebo, administered via the buccal transmucosal route, with a 2-week interval between each administration, during the placebo-controlled treatment period. All participants will have their symptoms monitored for 12 weeks in the placebo- controlled follow-up period, following the second administration of VLS-01-BU or placebo. After the placebo-controlled treatment and observation period all participants will be re-randomized 1:1 to receive one double-blinded administration of VLS-01-BU (dose strength 1 or dose strength 2) during a non-placebo-controlled treatment period. Final safety and efficacy assessment will be conducted two weeks after administration of the third dose.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
142

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, NSW 2050
        • Recruiting
        • Royal Prince Alfred Hospital
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Sydney Local Health District (SLHD) Mental Health
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Recruiting
        • NeuroCentrix
      • Carlton, Victoria, Australia, 3053
        • Recruiting
        • The University of Melbourne
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Royal Melbourne Hospital
      • Northcote, Victoria, Australia, 3070
        • Recruiting
        • Paratus Clinical Research Melbourne
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • University of Melbourne
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Royal Melbourne Hospital Parkville
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0E8
        • Recruiting
        • Centre for Neurology Studies
    • Ontario
      • Kingston, Ontario, Canada, K7L 4X3
        • Recruiting
        • Providence Care Hospital
  • United Kingdom
      • London, United Kingdom, W1G 8DR
        • Recruiting
        • Clerkenwell Health
    • England
      • Doncaster, England, United Kingdom, DN 4 8QN
        • Recruiting
        • Clerkenwell Health
      • London, England, United Kingdom, W1U 6RP
        • Recruiting
        • Clerkenwell Health
      • Motherwell, England, United Kingdom, ML1 4UF
        • Recruiting
        • NeuroClin
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Noble Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Preferred Research Partners, Inc.
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research, LLC
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest
    • California
      • Garden Grove, California, United States, 92845
        • Recruiting
        • CenExel
      • Glendale, California, United States, 91206
        • Recruiting
        • Behavioral Research Specialists, LLC
      • La Jolla, California, United States, 92037
        • Recruiting
        • Kadima Neuropsychiatry Institute
      • Los Alamitos, California, United States, 90720
        • Recruiting
        • Collaborative Neuroscience Research, LLC
      • Santa Monica, California, United States, 90404
        • Recruiting
        • TRIP Clinical at Psychedelic Science Institute
    • Colorado
      • Denver, Colorado, United States, 80209
        • Recruiting
        • Mountain View Clinical Research Inc.
        • Contact:
          • David Weiss, MD
          • Phone Number: 720-941-9363
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • CenExel
      • Miami, Florida, United States, 33155
        • Recruiting
        • BioResearch Partner
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida, Psychiatry and Behavioral Neurosciences
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • CenExcel
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Recruiting
        • Pillar Clinical Research LLC
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Sheppard Pratt
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Sunstone Medical, PC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Elixia MA
      • Watertown, Massachusetts, United States, 02472
        • Recruiting
        • Adams Clinical
    • Minnesota
      • Eden Prairie, Minnesota, United States, 55347
        • Recruiting
        • Institute for Integrative Therapies
    • Missouri
      • Saint Charles, Missouri, United States, 63304
        • Recruiting
        • Midwest Research Group
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Recruiting
        • Clinilabs, LLC
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Bio Behavioral Health
    • New York
      • New York, New York, United States, 10128
        • Recruiting
        • The Medical Research Network, LLC
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro Behavioral Clinical Research, Inc.
    • Pennsylvania
      • Moosic, Pennsylvania, United States, 18507
        • Recruiting
        • Scranton Medical Institute, LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • UNIVERSITY of PENNSYLVANIA
    • Texas
      • Austin, Texas, United States, 78759
        • Recruiting
        • BioBehavioral Research of Austin
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Insite clinical research
      • Plano, Texas, United States, 75093
        • Recruiting
        • AIM Trials, LLC
    • Utah
      • Draper, Utah, United States, 84020
        • Recruiting
        • Cedar Clinical Research Inc
    • Washington
      • Bellevue, Washington, United States, 98004
        • Recruiting
        • Seattle Neuropsychiatric Treatment Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: VLS-01-BU
Drug: VLS-01-203 BU
VLS-01 buccal transmucosal administration
Placebo Comparator: VLS-01-BU Placebo
Drug: VLS-01-BU Placebo
Placebo buccal transmucosal administration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time Frame: Baseline to Day 29
Baseline to Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline in MADRS total score
Time Frame: Baseline to Day 43
Baseline to Day 43

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Incidence and severity of adverse events, adverse events of special interest and serious adverse events
Time Frame: Baseline to Day 113
Baseline to Day 113
Incidence of clinically significant abnormalities in physical examinations, vital signs, electrocardiogram parameters, and safety laboratory results
Time Frame: Baseline to Day 113
Baseline to Day 113
Columbia-Suicide Severity Rating Scale (C- SSRS) scores
Time Frame: Baseline to Day 113
Baseline to Day 113

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
atai Therapeutics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kimball A Johnson, MD, CenExel iResearch, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VLS-01-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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