Actively Recruiting
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
Led by atai Therapeutics, Inc. · Updated on 2026-05-11
142
Participants Needed
48
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film VLS-01-BU in adults with treatment resistant Major Depressive Disorder TRD. This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants depressive symptoms will be regularly monitored using the Montgomery-sberg Depression Rating Scale MADRS from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.
CONDITIONS
Brief Title
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Major Depressive Disorder without psychotic features or single-episode MDD lasting 3 months or more without psychotic features and currently experiencing a major depressive episode.
- Onset of first depressive episode 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.
- Capable of giving signed informed consent and complying with study requirements.
You will not qualify if you...
- Has a current or prior diagnosis of schizophrenia spectrum, psychotic disorder, bipolar disorder, or any disorder with psychotic features.
- Has moderate or severe substance use disorder within 6 months before screening or history within 1 year before screening.
- Has diseases or conditions that would compromise well-being or interfere with study assessments.
- Has suicidal ideation with intent within 6 months before screening or history of suicidal behavior within 1 year before screening.
- Has significant cardiovascular, cerebrovascular, or peripheral vascular disease or risk factors for long QT Syndrome.
- Has active or recent malignancy within 2 years before screening, excluding certain skin cancers.
- Has known allergy or hypersensitivity to VLS-01 or excipients.
- Has started or plans to start directive psychotherapy within 30 days before screening or during the study.
- Has received any prohibited therapies.
- Has significant laboratory abnormalities at screening.
Research Team
K
Kevin Craig, MD
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