A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression
Purpose
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term VLS-01-BU treatment in patients with TRD and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.
Condition
- Treatment Resistant Depression
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 mild, 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 - 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 disorder (drug or alcohol) within the previous 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, hypertension, hypotension, bradycardia, or tachycardia. - 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 clinically significant laboratory abnormalities at Screening.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VLS-01-BU |
|
|
|
Placebo Comparator VLS-01-BU Placebo |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- atai Therapeutics, Inc.
Detailed Description
This Phase 2, multicenter, double-blind, randomized, placebo-controlled, trial will enroll approximately 142 participants with TRD, randomized 1:1 to receive a total of 2 double-blind administrations of VLS-01-BU (buccal film containing N,N dimethyltryptamine (DMT)) or placebo, administered via the buccal transmucosal route, with a 2-week interval between each administration, during the placebo-controlled treatment period. All participants will have their symptoms monitored for 12 weeks in the placebo-controlled follow-up period, following the second administration of VLS-01-BU or placebo. All participants will then be re-randomized 1:1 to receive one double-blinded administration of VLS-01-BU (dose strength 1 or dose strength 2) during the non-placebo-controlled treatment period. Final safety and efficacy assessment will be conducted two weeks after administration of the third dose.
