Treatment Resistant DepressionPhase 2NCT06524830
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
A Phase 2 study testing VLS-01-203 BU in people with Treatment Resistant Depression, run by atai Therapeutics, Inc. at 48 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- VLS-01-203 BU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 48 sitesin 4 countries
- Study dates
- 30 Dec 2024to 16 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
48 sites in 4 countries.
48 sites in 4 countries
United States34 sites
Biobehavioral Research of Austin
Austin, Texas, 78759
Sheppard Pratt
Baltimore, Maryland, 21204
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, 98004
Pillar Clinical Research LLC
Chicago, Illinois, 60641
The Ohio State University
Columbus, Ohio, 43210
CenExcel
Decatur, Georgia, 30030
Mountain View Clinical Research Inc.
Denver, Colorado, 80209
InSite Clinical Research
DeSoto, Texas, 75115
Cedar Clinical Research Inc
Draper, Utah, 84020
Clinilabs, LLC
Eatontown, New Jersey, 07724
Institute for Integrative Therapies
Eden Prairie, Minnesota, 55347
CenExel
Garden Grove, California, 92845
Behavioral Research Specialists, LLC
Glendale, California, 91206
CenExel
Hollywood, Florida, 33024
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
Bioresearch Partner
Miami, Florida, 33155
Scranton Medical Institute, LLC
Moosic, Pennsylvania, 18507
The Medical Research Network, LLC
New York, New York, 10128
Neuro Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Aim Trials, LLC
Plano, Texas, 75093
Sunstone Medical, PC
Rockville, Maryland, 20850
Woodland Research Northwest
Rogers, Arkansas, 72758
Midwest Research Group
Saint Charles, Missouri, 63304
TRIP Clinical at Psychedelic Science Institute
Santa Monica, California, 90404
CenExel
Savannah, Georgia, 31405
Elixia MA
Springfield, Massachusetts, 01103
University of South Florida, Psychiatry and Behavioral Neurosciences
Tampa, Florida, 33613
Bio Behavioral Health
Toms River, New Jersey, 08755
Noble Clinical Research
Tucson, Arizona, 85704
Adams Clinical
Watertown, Massachusetts, 02472
Australia8 sites
Sydney Local Health District (SLHD) Mental Health
Camperdown, New South Wales, 2050
Royal Prince Alfred Hospital
Camperdown, New South Wales, NSW 2050
NeuroCentrix
Carlton, Victoria, 3053
The University of Melbourne
Carlton, Victoria, 3053
Royal Melbourne Hospital
Melbourne, Victoria, 3000
Paratus Clinical Research Melbourne
Northcote, Victoria, 3070
Royal Melbourne Hospital Parkville
Parkville, Victoria, 3050
University of Melbourne
Parkville, Victoria, 3052
United Kingdom4 sites
Clerkenwell Health
Doncaster, England, DN 4 8QN
Clerkenwell Health
London, England, W1U 6RP
Clerkenwell Health
London, W1G 8DR
NeuroClin
Motherwell, England, ML1 4UF
Canada2 sites
Providence Care Hospital
Kingston, Ontario, K7L 4X3
Centre for Neurology Studies
Surrey, British Columbia, V3V 0E8
About this study
Official title: 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.
Read the 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.
- Conditions
- Treatment Resistant Depression
- Being tested
- VLS-01-203 BU, VLS-01-BU Placebo
- 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
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Mood Disorders, Mental Disorders, Depressive Disorder, Depression, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLS-01-203 BUDrug
VLS-01 buccal transmucosal administration
VLS-01-BU PlaceboDrug
Placebo buccal transmucosal administration
| Study group | Role | What they receive |
|---|---|---|
| VLS-01-BU | Experimental | Not described Receives: Drug: VLS-01-203 BU |
| VLS-01-BU Placebo | Placebo comparator | Not described Receives: Drug: VLS-01-BU Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Measured: Baseline to Day 29
Secondary outcomes (1)
Change from Baseline in MADRS total score
Measured: Baseline to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start30 Dec 2024
- Primary completion30 Jul 2026
- Study completion16 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- atai Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524830
- Sponsor's protocol ID
- VLS-01-203
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06524830
- Acronym / sponsor ID
- VLS-01-203
- Conditions
- Treatment Resistant Depression
- Keywords
- Major Depression, Mood Disorders, Mental Disorders, Depressive Disorder, Depression, Depressive Disorder, Major, Antidepressive Agents, Psychotropic Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- atai Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 16 Oct 2026 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLS-01-BU | Experimental | Drug: VLS-01-203 BU |
| VLS-01-BU Placebo | Placebo comparator | Drug: VLS-01-BU Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLS-01-203 BUVLS-01 buccal transmucosal administration | Drug | VLS-01-BU |
| VLS-01-BU PlaceboPlacebo buccal transmucosal administration | Drug | VLS-01-BU Placebo |
Primary outcome
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Time frame: Baseline to Day 29
1 secondary outcome
Change from Baseline in MADRS total score
Time frame: Baseline to Day 43
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
48 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VLS-01-203 BU in people with Treatment Resistant Depression, run by atai Therapeutics, Inc. at 48 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Australia, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score (time frame: Baseline to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.