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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 30, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06524830). This is a study registration, not published results. Lead sponsor: atai Therapeutics, Inc.. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 142 participants (ACTUAL). Conditions: Treatment Resistant Depression. Interventions: DRUG: VLS-01-203 BU; DRUG: VLS-01-BU Placebo. Primary outcome measures: Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score , Baseline to Day 29. 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.