OpenMedium-term (3–5 yrs)Treatment Study
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
For Condition: Treatment Resistant Depression
ID: NCT06524830
Horizon Patient Guidance Summary
Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:
How it’s taken
Diet & Lifestyle / Therapy Care
Expected Availability Horizon
Medium-term (3–5 yrs away)
StageMiddle Clinical Stage: Designed to check if the treatment actively works for the condition in moderate groups (100–300 people). Gathers early success indicators.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial
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 Full Scientific Objectives & Methods
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 Timeline & Quick Facts
Trial Status
Open — Looking for Participants
Total Target Enrollment
142 patients (Estimated)
Study Start Date
2024-12-30
Est. Primary Completion
2026-08-01
Tested Drugs & Treatment Groups
DRUGVLS-01-203 BU
VLS-01 buccal transmucosal administration
DRUGVLS-01-BU Placebo
Placebo buccal transmucosal administration
Treatment Arms Description
EXPERIMENTALVLS-01-BU
PLACEBO_COMPARATORVLS-01-BU Placebo
Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 18 Years and 65 Years
Full Criteria Checklist
Who Can 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.
- 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.
What is this Study Measuring?
Primary Outcome Measures
- Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score — Time Frame: Baseline to Day 29
View Secondary Outcome Measures (1)
- Change from Baseline in MADRS total score — Time Frame: Baseline to Day 43
Where to Participate
This trial is recruiting at 48 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 48 Facilities & Contact Sites
Noble Clinical Research
Tucson, Arizona, United States
Status: Open
Pillar Clinical Research, LLC
Little Rock, Arkansas, United States
Status: Open
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Status: Open
Woodland Research Northwest
Rogers, Arkansas, United States
Status: Open
CenExel
Garden Grove, California, United States
Status: Open
Behavioral Research Specialists, LLC
Glendale, California, United States
Status: Open
Kadima Neuropsychiatry Institute
La Jolla, California, United States
Status: Open
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States
Status: Open
TRIP Clinical at Psychedelic Science Institute
Santa Monica, California, United States
Status: Open
Mountain View Clinical Research Inc.
Denver, Colorado, United States
Status: Open
CenExel
Hollywood, Florida, United States
Status: Open
Bioresearch Partner
Miami, Florida, United States
Status: Open
University of South Florida, Psychiatry and Behavioral Neurosciences
Tampa, Florida, United States
Status: Open
CenExcel
Decatur, Georgia, United States
Status: Open
CenExel
Savannah, Georgia, United States
Status: Open
Pillar Clinical Research LLC
Chicago, Illinois, United States
Status: Open
Sheppard Pratt
Baltimore, Maryland, United States
Status: Open
Sunstone Medical, PC
Rockville, Maryland, United States
Status: Open
Elixia MA
Springfield, Massachusetts, United States
Status: Open
Adams Clinical
Watertown, Massachusetts, United States
Status: Open
Institute for Integrative Therapies
Eden Prairie, Minnesota, United States
Status: Open
Midwest Research Group
Saint Charles, Missouri, United States
Status: Open
Clinilabs, LLC
Eatontown, New Jersey, United States
Status: Open
Bio Behavioral Health
Toms River, New Jersey, United States
Status: Open
The Medical Research Network, LLC
New York, New York, United States
Status: Open
The Ohio State University
Columbus, Ohio, United States
Status: Open
Neuro Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
Status: Open
Scranton Medical Institute, LLC
Moosic, Pennsylvania, United States
Status: Open
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Status: Open
Biobehavioral Research of Austin
Austin, Texas, United States
Status: Open
InSite Clinical Research
DeSoto, Texas, United States
Status: Open
Aim Trials, LLC
Plano, Texas, United States
Status: Open
Cedar Clinical Research Inc
Draper, Utah, United States
Status: Open
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, United States
Status: Open
Sydney Local Health District (SLHD) Mental Health
Camperdown, New South Wales, Australia
Status: Open
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Status: Open
NeuroCentrix
Carlton, Victoria, Australia
Status: Open
The University of Melbourne
Carlton, Victoria, Australia
Status: Open
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Status: Open
Paratus Clinical Research Melbourne
Northcote, Victoria, Australia
Status: Open
Royal Melbourne Hospital Parkville
Parkville, Victoria, Australia
Status: Open
University of Melbourne
Parkville, Victoria, Australia
Status: Open
Centre for Neurology Studies
Surrey, British Columbia, Canada
Status: Open
Providence Care Hospital
Kingston, Ontario, Canada
Status: Open
Clerkenwell Health
Doncaster, England, United Kingdom
Status: Open
Clerkenwell Health
London, England, United Kingdom
Status: Open
NeuroClin
Motherwell, England, United Kingdom
Status: Open
Clerkenwell Health
London, United Kingdom
Status: Open
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
triple (participant, investigator, outcomes_assessor)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
atai Therapeutics, Inc.
Primary Research Contact
Clinical Trial Application Copilot
Want to apply or inquire about joining this study? Fill out this simple questionnaire, and our assistant will instantly generate a professional email draft you can copy and send to the central contact coordinator listed above!
Generated Professional Email Draft:
Draft ready to copy & send
Subject: Inquiry about clinical trial enrollment: NCT06524830 - A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Dear Study Coordinator / Research Team,
I hope this message finds you well.
My name is [Your Name], and I am writing to express my strong interest in participating in the clinical trial titled "A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)" (NCT ID: NCT06524830).
I am [Age] years old and have been diagnosed with Treatment Resistant Depression. I have reviewed the eligibility criteria for this study on Med Code Info and believe I may be a suitable candidate.
Could you please let me know if this study is actively enrolling patients at any site near my location, and what the next steps are to undergo screening?
Thank you for your time and research efforts.
Warm regards,
[Your Name]
View Official Medical/Scientific 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