A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
atai Therapeutics, Inc.
Study ID
NCT06524830
Phase
PHASE2
Status
Recruiting
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Conditions

  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • VLS-01-203 BU — DRUG
    VLS-01 buccal transmucosal administration
  • VLS-01-BU Placebo — DRUG
    Placebo buccal transmucosal administration

Study Details

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.

Key Dates

Start date
Dec 30, 2024
Status verified
May 2026
Primary completion
Aug 1, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
142 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: VLS-01-BU
  • Placebo Comparator: VLS-01-BU Placebo

Primary Outcome Measure

Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score [ Time Frame: Baseline to Day 29 ]

Central Contacts

Locations (34)

FacilityCityStateZIPSite coordinators
Noble Clinical ResearchTucsonArizona85704-
Pillar Clinical Research, LLCLittle RockArkansas72204-
Preferred Research Partners, Inc.Little RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758-
CenExelGarden GroveCalifornia92845-
Behavioral Research Specialists, LLCGlendaleCalifornia91206-
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720-
TRIP Clinical at Psychedelic Science InstituteSanta MonicaCalifornia90404-
Mountain View Clinical Research Inc.DenverColorado80209-
CenExelHollywoodFlorida33024-
Bioresearch PartnerMiamiFlorida33155-
University of South Florida, Psychiatry and Behavioral NeurosciencesTampaFlorida33613-
CenExcelDecaturGeorgia30030-
CenExelSavannahGeorgia31405-
Pillar Clinical Research LLCChicagoIllinois60641-
Sheppard PrattBaltimoreMaryland21204-
Sunstone Medical, PCRockvilleMaryland20850-
Elixia MASpringfieldMassachusetts01103-
Adams ClinicalWatertownMassachusetts02472-
Institute for Integrative TherapiesEden PrairieMinnesota55347-
Midwest Research GroupSaint CharlesMissouri63304-
Clinilabs, LLCEatontownNew Jersey07724-
Bio Behavioral HealthToms RiverNew Jersey08755-
The Medical Research Network, LLCNew YorkNew York10128-
The Ohio State UniversityColumbusOhio43210-
Neuro Behavioral Clinical Research, Inc.North CantonOhio44720-
Scranton Medical Institute, LLCMoosicPennsylvania18507-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Biobehavioral Research of AustinAustinTexas78759-
InSite Clinical ResearchDeSotoTexas75115-
Aim Trials, LLCPlanoTexas75093-
Cedar Clinical Research IncDraperUtah84020-
Seattle Neuropsychiatric Treatment CenterBellevueWashington98004-

Find similar trials in Tucson, AZ

By research site
Noble Clinical Research· Tucson, AZPillar Clinical Research, LLC· Little Rock, ARPreferred Research Partners, Inc.· Little Rock, ARWoodland Research Northwest· Rogers, ARCenExel· Garden Grove, CABehavioral Research Specialists, LLC· Glendale, CA

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