RECRUITING

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

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Conditions

Treatment Resistant DepressionMajor DepressionMood DisordersMental DisordersDepressive DisorderDepressionDepressive Disorder, MajorAntidepressive AgentsPsychotropic DrugsBehavioral SymptomsDepressive Disorder, Treatment-Resistant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-12-30
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06524830

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant must be 18 to 65 years of age inclusive at the time of signing the Informed Consent.
  2. * 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.
  3. * Onset of first episode of MDD occurred before age 55.
  4. * 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).
  5. * 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.
  1. * 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.
  2. * 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
  3. * 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.
  4. * 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.
  5. * 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.
  6. * Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years before Screening.
  7. * Has any known allergy or hypersensitivity to VLS-01 or to any of the excipients in the formulation.
  8. * 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.
  9. * Has received any prohibited therapies.
  10. * Has clinically significant laboratory abnormalities at Screening.

Contacts and Locations

Study Contact

Kevin Craig, MD
CONTACT
332-282-0507
clinicaltrials@atai.life

Study Locations (Sites)

Woodland Research Northwest
Woodland, Arkansas, 72758
United States
Mountain View Clinical Research Inc.
Denver, Colorado, 80209
United States
InSite Clinical Research
DeSoto, Texas, 75115
United States

Collaborators and Investigators

Sponsor: atai Therapeutics, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-30
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2024-12-30
Study Completion Date2026-03-30

Terms related to this study

Keywords Provided by Researchers

  • Major Depression
  • Mood Disorders
  • Mental Disorders
  • Depressive Disorder
  • Depression
  • Depressive Disorder, Major
  • Antidepressive Agents
  • Psychotropic Drugs
  • Treatment Resistant Depression
  • Behavioral Symptoms
  • Depressive Disorder, Treatment-Resistant

Additional Relevant MeSH Terms

  • Treatment Resistant Depression