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RecruitingNCT06524830

VLS-01-203 BU for treatment-resistant depression

The registry lists this study as recruiting. Study locations are listed in the United States, in Australia, in Canada, ... Confirm recruitment at each site. It is testing VLS-01-203 BU for treatment-resistant depression.

DepressionDrugFrom 18 Years to 65 Years
In plain English

Key information made simple

What is this study testing?

This study is testing whether VLS-01-203 BU may be useful for adults experiencing depression.

What would participation involve?

Participants may receive VLS-01-203 BU, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Australia, in Canada, and in the United Kingdom.

Who is it mainly for?

This study appears to be mainly for adults with depression.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: December 30, 2024
Recruitment status
Recruiting
Enrollment listed in the registry
142
Sponsor
atai Therapeutics, Inc.
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Australia, Canada, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT06524830
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

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Australia · 8 sites
  • Sydney Local Health District (SLHD) Mental Health
    Camperdown, New South Wales
    Site status: Recruiting
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales
    Site status: Recruiting
  • NeuroCentrix
    Carlton, Victoria
    Site status: Recruiting
  • The University of Melbourne
    Carlton, Victoria
    Site status: Recruiting
  • Royal Melbourne Hospital
    Melbourne, Victoria
    Site status: Recruiting
  • Paratus Clinical Research Melbourne
    Northcote, Victoria
    Site status: Recruiting
  • Royal Melbourne Hospital Parkville
    Parkville, Victoria
    Site status: Recruiting
  • University of Melbourne
    Parkville, Victoria
    Site status: Recruiting
Canada · 2 sites
  • Centre for Neurology Studies
    Surrey, British Columbia
    Site status: Recruiting
  • Providence Care Hospital
    Kingston, Ontario
    Site status: Recruiting
United Kingdom · 4 sites
  • Clerkenwell Health
    Doncaster, England
    Site status: Recruiting
  • Clerkenwell Health
    London, England
    Site status: Recruiting
  • NeuroClin
    Motherwell, England
    Site status: Recruiting
  • Clerkenwell Health
    London
    Site status: Recruiting
United States · 34 sites
  • Noble Clinical Research
    Tucson, Arizona
    Site status: Recruiting
  • Pillar Clinical Research, LLC
    Little Rock, Arkansas
    Site status: Recruiting
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas
    Site status: Recruiting
  • Woodland Research Northwest
    Rogers, Arkansas
    Site status: Recruiting
  • CenExel
    Garden Grove, California
    Site status: Recruiting
  • Behavioral Research Specialists, LLC
    Glendale, California
    Site status: Recruiting
  • Kadima Neuropsychiatry Institute
    La Jolla, California
    Site status: Recruiting
  • Collaborative Neuroscience Research, LLC
    Los Alamitos, California
    Site status: Recruiting
  • TRIP Clinical at Psychedelic Science Institute
    Santa Monica, California
    Site status: Recruiting
  • Mountain View Clinical Research Inc.
    Denver, Colorado
    Site status: Recruiting
  • CenExel
    Hollywood, Florida
    Site status: Recruiting
  • Bioresearch Partner
    Miami, Florida
    Site status: Recruiting
  • University of South Florida, Psychiatry and Behavioral Neurosciences
    Tampa, Florida
    Site status: Recruiting
  • CenExcel
    Decatur, Georgia
    Site status: Recruiting
  • CenExel
    Savannah, Georgia
    Site status: Recruiting
  • Pillar Clinical Research LLC
    Chicago, Illinois
    Site status: Recruiting
  • Sheppard Pratt
    Baltimore, Maryland
    Site status: Recruiting
  • Sunstone Medical, PC
    Rockville, Maryland
    Site status: Recruiting
  • Elixia MA
    Springfield, Massachusetts
    Site status: Recruiting
  • Adams Clinical
    Watertown, Massachusetts
    Site status: Recruiting
  • Institute for Integrative Therapies
    Eden Prairie, Minnesota
    Site status: Recruiting
  • Midwest Research Group
    Saint Charles, Missouri
    Site status: Recruiting
  • Clinilabs, LLC
    Eatontown, New Jersey
    Site status: Recruiting
  • Bio Behavioral Health
    Toms River, New Jersey
    Site status: Recruiting
  • The Medical Research Network, LLC
    New York, New York
    Site status: Recruiting
  • The Ohio State University
    Columbus, Ohio
    Site status: Recruiting
  • Neuro Behavioral Clinical Research, Inc.
    North Canton, Ohio
    Site status: Recruiting
  • Scranton Medical Institute, LLC
    Moosic, Pennsylvania
    Site status: Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania
    Site status: Recruiting
  • Biobehavioral Research of Austin
    Austin, Texas
    Site status: Recruiting
  • InSite Clinical Research
    DeSoto, Texas
    Site status: Recruiting
  • Aim Trials, LLC
    Plano, Texas
    Site status: Recruiting
  • Cedar Clinical Research Inc
    Draper, Utah
    Site status: Recruiting
  • Seattle Neuropsychiatric Treatment Center
    Bellevue, Washington
    Site status: Recruiting
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with depression. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving VLS-01-203 BU, VLS-01-BU Placebo. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with depression; age range: From 18 Years to 65 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by atai Therapeutics, Inc., which appears to be a biotech company. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as recruiting. Individual sites may have different statuses. The research team must confirm whether a site is open and whether you meet the criteria.

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