Actively Recruiting
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
Led by atai Therapeutics, Inc. · Updated on 2026-05-11
142
Participants Needed
48
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of VLS-01 buccal film (VLS-01-BU) in adults with treatment resistant Major Depressive Disorder (TRD). This Phase 2, multicenter, randomized, placebo-controlled trial aims to understand the onset and duration of antidepressant effects of VLS-01-BU compared to placebo in patients who have not responded to previous treatments. Participants will be randomly assigned to receive two doses of either VLS-01-BU or placebo administered via a buccal transmucosal film, with two weeks between doses. After a 12-week follow-up monitoring period, all participants will be re-randomized to receive one additional dose of VLS-01-BU at one of two dose strengths. Safety and efficacy will be assessed two weeks after this third dose during a non-placebo-controlled treatment phase. Throughout the study, participants' depressive symptoms will be regularly monitored using the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to Day 29 and through Day 43. The study includes multiple assessments to measure the antidepressant effects and safety of the treatment. The total duration of participant involvement covers the initial dosing, follow-up, re-randomization, and final evaluation, ensuring thorough observation of treatment impact and tolerability.
CONDITIONS
Brief Title
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 Major Depressive Disorder without psychotic features or single-episode MDD lasting 3 months or more without psychotic features and currently experiencing a major depressive episode.
- Onset of first depressive episode 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.
- Capable of giving signed informed consent and complying with study requirements.
You will not qualify if you...
- Has a current or prior diagnosis of schizophrenia spectrum, psychotic disorder, bipolar disorder, or any disorder with psychotic features.
- Has moderate or severe substance use disorder within 6 months before screening or history within 1 year before screening.
- Has diseases or conditions that would compromise well-being or interfere with study assessments.
- Has suicidal ideation with intent within 6 months before screening or history of suicidal behavior within 1 year before screening.
- Has significant cardiovascular, cerebrovascular, or peripheral vascular disease or risk factors for long QT Syndrome.
- Has active or recent malignancy within 2 years before screening, excluding certain skin cancers.
- Has known allergy or hypersensitivity to VLS-01 or excipients.
- Has started or plans to start directive psychotherapy within 30 days before screening or during the study.
- Has received any prohibited therapies.
- Has significant laboratory abnormalities at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive two administrations of VLS-01 buccal film or placebo via the buccal transmucosal route with a 2-week interval between doses.
2 visits spaced 2 weeks apart
Duration - 12 weeks
Participants' symptoms are monitored following the second administration to assess efficacy and safety.
Periodic visits during follow-up
Duration - Single dose administration plus 2 week observation
Participants are re-randomized to receive one double-blinded administration of VLS-01 buccal film at one of two dose strengths.
1 administration visit and 1 follow-up visit 2 weeks later
Trial Site Locations
Total: 48 locations
1
Noble Clinical Research
Tucson, Arizona, United States, 85704
Actively Recruiting
2
Pillar Clinical Research, LLC
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Actively Recruiting
5
CenExel
Garden Grove, California, United States, 92845
Actively Recruiting
6
Behavioral Research Specialists, LLC
Glendale, California, United States, 91206
Actively Recruiting
7
Kadima Neuropsychiatry Institute
La Jolla, California, United States, 92037
Actively Recruiting
8
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720
Actively Recruiting
9
TRIP Clinical at Psychedelic Science Institute
Santa Monica, California, United States, 90404
Actively Recruiting
10
Mountain View Clinical Research Inc.
Denver, Colorado, United States, 80209
Actively Recruiting
11
CenExel
Hollywood, Florida, United States, 33024
Actively Recruiting
12
Bioresearch Partner
Miami, Florida, United States, 33155
Actively Recruiting
13
University of South Florida, Psychiatry and Behavioral Neurosciences
Tampa, Florida, United States, 33613
Actively Recruiting
14
CenExcel
Decatur, Georgia, United States, 30030
Actively Recruiting
15
CenExel
Savannah, Georgia, United States, 31405
Actively Recruiting
16
Pillar Clinical Research LLC
Chicago, Illinois, United States, 60641
Actively Recruiting
17
Sheppard Pratt
Baltimore, Maryland, United States, 21204
Actively Recruiting
18
Sunstone Medical, PC
Rockville, Maryland, United States, 20850
Actively Recruiting
19
Elixia MA
Springfield, Massachusetts, United States, 01103
Actively Recruiting
20
Adams Clinical
Watertown, Massachusetts, United States, 02472
Actively Recruiting
21
Institute for Integrative Therapies
Eden Prairie, Minnesota, United States, 55347
Actively Recruiting
22
Midwest Research Group
Saint Charles, Missouri, United States, 63304
Actively Recruiting
23
Clinilabs, LLC
Eatontown, New Jersey, United States, 07724
Actively Recruiting
24
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
Actively Recruiting
25
The Medical Research Network, LLC
New York, New York, United States, 10128
Actively Recruiting
26
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
27
Neuro Behavioral Clinical Research, Inc.
North Canton, Ohio, United States, 44720
Actively Recruiting
28
Scranton Medical Institute, LLC
Moosic, Pennsylvania, United States, 18507
Actively Recruiting
29
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Biobehavioral Research of Austin
Austin, Texas, United States, 78759
Actively Recruiting
31
InSite Clinical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
32
Aim Trials, LLC
Plano, Texas, United States, 75093
Actively Recruiting
33
Cedar Clinical Research Inc
Draper, Utah, United States, 84020
Actively Recruiting
34
Seattle Neuropsychiatric Treatment Center
Bellevue, Washington, United States, 98004
Actively Recruiting
35
Sydney Local Health District (SLHD) Mental Health
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
36
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, NSW 2050
Actively Recruiting
37
NeuroCentrix
Carlton, Victoria, Australia, 3053
Actively Recruiting
38
The University of Melbourne
Carlton, Victoria, Australia, 3053
Actively Recruiting
39
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3000
Actively Recruiting
40
Paratus Clinical Research Melbourne
Northcote, Victoria, Australia, 3070
Actively Recruiting
41
Royal Melbourne Hospital Parkville
Parkville, Victoria, Australia, 3050
Actively Recruiting
42
University of Melbourne
Parkville, Victoria, Australia, 3052
Actively Recruiting
43
Centre for Neurology Studies
Surrey, British Columbia, Canada, V3V 0E8
Actively Recruiting
44
Providence Care Hospital
Kingston, Ontario, Canada, K7L 4X3
Actively Recruiting
45
Clerkenwell Health
Doncaster, England, United Kingdom, DN 4 8QN
Actively Recruiting
46
Clerkenwell Health
London, England, United Kingdom, W1U 6RP
Actively Recruiting
47
NeuroClin
Motherwell, England, United Kingdom, ML1 4UF
Actively Recruiting
48
Clerkenwell Health
London, United Kingdom, W1G 8DR
Actively Recruiting
Research Team
K
Kevin Craig, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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