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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 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.

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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

Treatment-Resistant Depression

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

FieldValue
Enrollment Target 142 participants
Start Date 2024-12-30
Est. Completion 2026-03-30
Phase Phase 2

Sponsor

atai Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06524830

The ClinicalTrials.gov registry entry for NCT06524830 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 371-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (62% lower). The listed sponsor is atai Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.