Clinical TrialParallelDepressive DisordersDMTPlaceboRecruiting

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 II, randomised, triple-blind, placebo-controlled trial (n=142) is evaluating VLS-01, a buccal film formulation of DMT, in adults with treatment-resistant depression. Participants receive VLS-01 or matching placebo twice, with administrations separated by 2 weeks, followed by 12 weeks of monitoring for the onset and durability of antidepressant effects. The primary outcome is change from baseline in Montgomery-Åsberg Depression Rating Scale total score at Day 29, with a key secondary assessment at Day 43 and safety monitoring through Day 113. After the placebo-controlled period, participants are re-randomised to receive one additional active VLS-01 administration at one of two dose strengths.

Ask Blossom about this trial
Target Enrollment
142 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Continue exploring

Continue exploring this trial

Move from the registry record to the most relevant public research context.

Compound research: DMTTopic research: Depressive DisordersResearch in United States

Detailed Description

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.

Study Arms & Interventions

VLS-01-BU

experimental

Interventions

  • DMT
    via Other• two administrations, 2 weeks apart• 2 doses total

    Buccal transmucosal VLS-01 (DMT); a third active dose follows re-randomisation after the controlled period.

Placebo (matched to VLS-01-BU)

inactive

Interventions

  • Placebo
    via Other• two administrations, 2 weeks apart• 2 doses total

    Buccal transmucosal placebo during the controlled treatment period.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Participant must be 18 to 65 years of age inclusive at the time of signing the Informed Consent.
  • Has a diagnosis of recurrent moderate or severe MDD without psychotic features or single- episode MDD with duration greater than or equal to 3 months without psychotic features and is currently experiencing a major depressive episode.
  • Onset of first episode of MDD occurred before age 55.
  • Has not responded to an adequate dose and duration of at least two and no more than five antidepressant medications for the current depressive episode, as determined by the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH- ATRQ).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion Criteria

  • Has a current or prior DSM-5-TR diagnosis of a schizophrenia spectrum and other psychotic disorder, substance/medication-induced psychotic disorder, bipolar and related disorder, or any disorder with psychotic features.
  • Has a moderate or severe substance use disorder (drug, alcohol, or tobacco) within the 6 months before Screening and/or history of moderate or severe substance use disorder (drug alcohol) within the previous 1 year before Screening
  • Has a history of, or current signs and symptoms of, diseases or conditions that would make participation not be in the best interest (e.g., compromise the wellbeing) of the participant or that could prevent, limit, or confound the protocol-specified assessments.
  • Has suicidal ideation with some intent to act within 6 months before Screening or a history of suicidal behavior within the past 1 year before Screening.
  • Has a history of clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease or condition, including but not limited to unstable angina, myocardial infarction, congestive heart failure, cardiac arrhythmia, valvular heart disease, obstructive coronary artery disease, hypertension, hypotension, bradycardia, tachycardia, or risk factors for long QT Syndrome.
  • Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before Screening.
  • Has any known allergy or hypersensitivity to VLS-01 or to any of the excipients in the formulation.
  • Has recently initiated and is currently undergoing directive psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy) within the past 30 days before Screening. Participants planning to initiate individual or group therapy during the study are also not eligible.
  • Has received any prohibited therapies.
  • Has clinically significant laboratory abnormalities at Screening.

Study Protocol, Arms & Participants

Go Pro to access detailed study protocol timelines, treatment arms, dosing schedules, and participant eligibility criteria.

See Pro Plans

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedtriple Blind
  • Target Enrollment142 participants
  • Timeline
    Start: 2024-12-30
    End: 2026-08-30
  • Compounds
    DMTPlacebo
  • Topic
    Depressive Disorders

Study Team

Sponsors & Collaborators

Locations

Noble Clinical Research — Tucson, Arizona, United States
Pillar Clinical Research, LLC — Little Rock, Arkansas, United States
Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
Woodland Research Northwest — Rogers, Arkansas, United States
CenExel — Garden Grove, California, United States
Behavioral Research Specialists, LLC — Glendale, California, United States
Kadima Neuropsychiatry Institute — La Jolla, California, United States
Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
TRIP Clinical at Psychedelic Science Institute — Santa Monica, California, United States
Mountain View Clinical Research Inc. — Denver, Colorado, United States
CenExel — Hollywood, Florida, United States
Bioresearch Partner — Miami, Florida, United States
University of South Florida, Psychiatry and Behavioral Neurosciences — Tampa, Florida, United States
CenExcel — Decatur, Georgia, United States
CenExel — Savannah, Georgia, United States
Pillar Clinical Research LLC — Chicago, Illinois, United States
Sheppard Pratt — Baltimore, Maryland, United States
Sunstone Medical, PC — Rockville, Maryland, United States
Elixia MA — Springfield, Massachusetts, United States
Adams Clinical — Watertown, Massachusetts, United States
Institute for Integrative Therapies — Eden Prairie, Minnesota, United States
Midwest Research Group — Saint Charles, Missouri, United States
Clinilabs, LLC — Eatontown, New Jersey, United States
Bio Behavioral Health — Toms River, New Jersey, United States
The Medical Research Network, LLC — New York, New York, United States
The Ohio State University — Columbus, Ohio, United States
Neuro Behavioral Clinical Research, Inc. — North Canton, Ohio, United States
Scranton Medical Institute, LLC — Moosic, Pennsylvania, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Biobehavioral Research of Austin — Austin, Texas, United States
InSite Clinical Research — DeSoto, Texas, United States
Aim Trials, LLC — Plano, Texas, United States
Cedar Clinical Research Inc — Draper, Utah, United States
Seattle Neuropsychiatric Treatment Center — Bellevue, Washington, United States
Sydney Local Health District (SLHD) Mental Health — Camperdown, New South Wales, Australia
Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
NeuroCentrix — Carlton, Victoria, Australia
The University of Melbourne — Carlton, Victoria, Australia
Royal Melbourne Hospital — Melbourne, Victoria, Australia
Paratus Clinical Research Melbourne — Northcote, Victoria, Australia
Royal Melbourne Hospital Parkville — Parkville, Victoria, Australia
University of Melbourne — Parkville, Victoria, Australia
Centre for Neurology Studies — Surrey, British Columbia, Canada
Providence Care Hospital — Kingston, Ontario, Canada
Clerkenwell Health — Doncaster, England, United Kingdom
Clerkenwell Health — London, England, United Kingdom
NeuroClin — Motherwell, England, United Kingdom
Clerkenwell Health — London, United Kingdom

Recent activity

  • StartedA Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients… (NCT06524830, dmt)

Your Personal Research Library

Go Pro to save trials, add notes, rate research, and organize custom shelves.

See Pro Plans