A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Recruiting · NCT06524830 · Interventional (participants receive a specific treatment) · Lead sponsor: atai Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
VLS-01-203 BUVLS-01-BU Placebo
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
48 locations listed across 18 US states.
- Noble Clinical Research - Tucson, Arizona, United States
- Pillar Clinical Research, LLC - Little Rock, Arkansas, United States
- Preferred Research Partners, Inc. - Little Rock, Arkansas, United States
- Woodland Research Northwest - Rogers, Arkansas, United States
- CenExel - Garden Grove, California, United States
- Behavioral Research Specialists, LLC - Glendale, California, United States
- Kadima Neuropsychiatry Institute - La Jolla, California, United States
- Collaborative Neuroscience Research, LLC - Los Alamitos, California, United States
- TRIP Clinical at Psychedelic Science Institute - Santa Monica, California, United States
- Mountain View Clinical Research Inc. - Denver, Colorado, United States
- CenExel - Hollywood, Florida, United States
- Bioresearch Partner - Miami, Florida, United States
- University of South Florida, Psychiatry and Behavioral Neurosciences - Tampa, Florida, United States
- CenExcel - Decatur, Georgia, United States
- CenExel - Savannah, Georgia, United States
- Pillar Clinical Research LLC - Chicago, Illinois, United States
- Sheppard Pratt - Baltimore, Maryland, United States
- Sunstone Medical, PC - Rockville, Maryland, United States
- Elixia MA - Springfield, Massachusetts, United States
- Adams Clinical - Watertown, Massachusetts, United States
- Institute for Integrative Therapies - Eden Prairie, Minnesota, United States
- Midwest Research Group - Saint Charles, Missouri, United States
- Clinilabs, LLC - Eatontown, New Jersey, United States
- Bio Behavioral Health - Toms River, New Jersey, United States
- The Medical Research Network, LLC - New York, New York, United States
- The Ohio State University - Columbus, Ohio, United States
- Neuro Behavioral Clinical Research, Inc. - North Canton, Ohio, United States
- Scranton Medical Institute, LLC - Moosic, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Biobehavioral Research of Austin - Austin, Texas, United States
- InSite Clinical Research - DeSoto, Texas, United States
- Aim Trials, LLC - Plano, Texas, United States
- Cedar Clinical Research Inc - Draper, Utah, United States
- Seattle Neuropsychiatric Treatment Center - Bellevue, Washington, United States
- Clerkenwell Health - London, United Kingdom
- Centre for Neurology Studies - Surrey, British Columbia, Canada
- Clerkenwell Health - Doncaster, England, United Kingdom
- Clerkenwell Health - London, England, United Kingdom
- NeuroClin - Motherwell, England, United Kingdom
- Sydney Local Health District (SLHD) Mental Health - Camperdown, New South Wales, Australia
- Royal Prince Alfred Hospital - Camperdown, New South Wales, Australia
- Providence Care Hospital - Kingston, Ontario, Canada
- NeuroCentrix - Carlton, Victoria, Australia
- The University of Melbourne - Carlton, Victoria, Australia
- Royal Melbourne Hospital - Melbourne, Victoria, Australia
- Paratus Clinical Research Melbourne - Northcote, Victoria, Australia
- Royal Melbourne Hospital Parkville - Parkville, Victoria, Australia
- University of Melbourne - Parkville, Victoria, Australia