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NCT06524830 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
A Phase 2 study of Treatment-Resistant Depression, sponsored by atai Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 20
- Study locations
NCT06524830: Recruiting Phase 2 study of Treatment-Resistant Depression, sponsored by atai Therapeutics.
NCT06524830 is a Phase 2 study of Treatment-Resistant Depression that is actively recruiting participants, run by atai Therapeutics. The registered enrollment target is 142 participants, below the 371-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06524830, a Phase 2 study of Treatment-Resistant Depression, is actively recruiting participants, sponsored by atai Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG VLS-01-203 BU
- DRUG VLS-01-BU Placebo
Study Locations (20)
California
- CenExel - Garden Grove
- Behavioral Research Specialists, LLC - Glendale
- Kadima Neuropsychiatry Institute - La Jolla
- TRIP Clinical at Psychedelic Science Institute - Santa Monica
Arkansas
- Pillar Clinical Research, LLC - Little Rock
- Preferred Research Partners, Inc. - Little Rock
- Woodland Research Northwest - Rogers
Florida
- CenExel - Hollywood
- Bioresearch Partner - Miami
- University of South Florida, Psychiatry and Behavioral Neurosciences - Tampa
Georgia
- CenExcel - Decatur
- CenExel - Savannah
Massachusetts
- Elixia MA - Springfield
- Adams Clinical - Watertown
Arizona
- Noble Clinical Research - Tucson
Colorado
- Mountain View Clinical Research Inc. - Denver
Illinois
- Pillar Clinical Research LLC - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2024-12-30 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 2 |
What NCT06524830 shows while recruiting
NCT06524830 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 371-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 2 interventions - of which VLS-01-203 BU is the first listed.
NCT06524830 names 20 study sites across 11 states, led by California, Arkansas, Florida.
Frequently Asked Questions
What is clinical trial NCT06524830 about?
NCT06524830 is a clinical study titled "A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)". 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 anti...
What is the current status of trial NCT06524830?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2024-12-30. Estimated completion is 2026-03-30.
What conditions does trial NCT06524830 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT06524830?
The interventions under investigation include: VLS-01-203 BU (DRUG), VLS-01-BU Placebo (DRUG).
Who is sponsoring clinical trial NCT06524830?
This trial is sponsored by atai Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06524830 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06524830's enrollment target sits among peer trials
142 13th of 54 higher than 42 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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