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)
| NCT ID | NCT06524830 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | atai Therapeutics, Inc. |
| Condition | Treatment Resistant Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2026-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 142 participants in total. It began in 2024-12-30 with a primary completion date of 2026-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 of VLS-01-BU versus placebo.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06524830 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Treatment Resistant Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06524830 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06524830 currently recruiting?
Yes, NCT06524830 is actively recruiting participants. Contact the research team at clinicaltrials@atai.life for enrollment information.
Where is the NCT06524830 trial being conducted?
This trial is being conducted at Tucson, United States, Little Rock, United States, Little Rock, United States, Rogers, United States and 11 additional locations.
Who is sponsoring the NCT06524830 clinical trial?
NCT06524830 is sponsored by atai Therapeutics, Inc.. The trial plans to enroll 142 participants.
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