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 now · Phase 2 · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT06524830

Run by

atai Therapeutics, Inc.

People needed

142

Starts

2024-12-30

Expected to finish

2026-08-30

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Noble Clinical Research — Tucson, Arizona, United States (enrolling)
• Pillar Clinical Research, LLC — Little Rock, Arkansas, United States (enrolling)
• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States (enrolling)
• Woodland Research Northwest — Rogers, Arkansas, United States (enrolling)
• CenExel — Garden Grove, California, United States (enrolling)
• Behavioral Research Specialists, LLC — Glendale, California, United States (enrolling)
• Kadima Neuropsychiatry Institute — La Jolla, California, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States (enrolling)
• TRIP Clinical at Psychedelic Science Institute — Santa Monica, California, United States (enrolling)
• Mountain View Clinical Research Inc. — Denver, Colorado, United States (enrolling)
• CenExel — Hollywood, Florida, United States (enrolling)
• Bioresearch Partner — Miami, Florida, United States (enrolling)
• University of South Florida, Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States (enrolling)
• CenExcel — Decatur, Georgia, United States (enrolling)
• CenExel — Savannah, Georgia, United States (enrolling)
• Pillar Clinical Research LLC — Chicago, Illinois, United States (enrolling)
• Sheppard Pratt — Baltimore, Maryland, United States (enrolling)
• Sunstone Medical, PC — Rockville, Maryland, United States (enrolling)
• Elixia MA — Springfield, Massachusetts, United States (enrolling)
• Adams Clinical — Watertown, Massachusetts, United States (enrolling)
• Institute for Integrative Therapies — Eden Prairie, Minnesota, United States (enrolling)
• Midwest Research Group — Saint Charles, Missouri, United States (enrolling)
• Clinilabs, LLC — Eatontown, New Jersey, United States (enrolling)
• Bio Behavioral Health — Toms River, New Jersey, United States (enrolling)
• The Medical Research Network, LLC — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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