A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Public ClinicalTrials.gov record NCT06524830. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06524830
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- atai Therapeutics, Inc.
- Industry
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Interventions
- VLS-01-203 BU Drug
- VLS-01-BU Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 29, 2024
- Primary completion
- Jul 31, 2026
- Completion
- Aug 29, 2026
- Last update posted
- May 5, 2026
2024 – 2026
United States locations
- U.S. sites
- 34
- U.S. states
- 18
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Noble Clinical Research | Tucson | Arizona | 85704 | Recruiting |
| Pillar Clinical Research, LLC | Little Rock | Arkansas | 72204 | Recruiting |
| Preferred Research Partners, Inc. | Little Rock | Arkansas | 72211 | Recruiting |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | Recruiting |
| CenExel | Garden Grove | California | 92845 | Recruiting |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | Recruiting |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | Recruiting |
| Collaborative Neuroscience Research, LLC | Los Alamitos | California | 90720 | Recruiting |
| TRIP Clinical at Psychedelic Science Institute | Santa Monica | California | 90404 | Recruiting |
| Mountain View Clinical Research Inc. | Denver | Colorado | 80209 | Recruiting |
| CenExel | Hollywood | Florida | 33024 | Recruiting |
| Bioresearch Partner | Miami | Florida | 33155 | Recruiting |
| University of South Florida, Psychiatry and Behavioral Neurosciences | Tampa | Florida | 33613 | Recruiting |
| CenExcel | Decatur | Georgia | 30030 | Recruiting |
| CenExel | Savannah | Georgia | 31405 | Recruiting |
| Pillar Clinical Research LLC | Chicago | Illinois | 60641 | Recruiting |
| Sunstone Medical, PC | Rockville | Maryland | 20850 | Recruiting |
| Elixia MA | Springfield | Massachusetts | 01103 | Recruiting |
| Adams Clinical | Watertown | Massachusetts | 02472 | Recruiting |
| Institute for Integrative Therapies | Eden Prairie | Minnesota | 55347 | Recruiting |
| Midwest Research Group | Saint Charles | Missouri | 63304 | Recruiting |
| Clinilabs, LLC | Eatontown | New Jersey | 07724 | Recruiting |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | Recruiting |
| The Medical Research Network, LLC | New York | New York | 10128 | Recruiting |
| ACM Global Laboratories | Rochester | New York | 14624 | Recruiting |
| The Ohio State University | Columbus | Ohio | 43210 | Recruiting |
| Neuro Behavioral Clinical Research, Inc. | North Canton | Ohio | 44720 | Recruiting |
| Scranton Medical Institute, LLC | Moosic | Pennsylvania | 18507 | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Biobehavioral Research of Austin | Austin | Texas | 78759 | Recruiting |
| InSite Clinical Research | DeSoto | Texas | 75115 | Recruiting |
| Aim Trials, LLC | Plano | Texas | 75093 | Recruiting |
| Cedar Clinical Research Inc | Draper | Utah | 84020 | Recruiting |
| Seattle Neuropsychiatric Treatment Center | Bellevue | Washington | 98004 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06524830, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced May 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06524830 live on ClinicalTrials.gov.