A Study to Assess the Efficacy, Safety and Tolerability of VLS-01-Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (TRD)
RECRUITMENT FOR STUDY
Study Sponsored by Atai Therapeutics, Inc.
This Phase 2, multicenter study 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.
Introduction and Rationale for Study
An estimated 280 million adults and adolescents globally meet the criteria for Major Depressive Disorder (MDD), and approximately 10–30% are treatment-resistant. Patients meet the definition of treatment-resistant if they have MDD and have not responded to at least two different antidepressant treatments of adequate doses and duration.
This trial is using VLS-01-BU, developed by atai Therapeutics Inc., for TRD in adults aged 18 to 65 years. VLS-01-BU contains N,N-dimethyltryptamine (DMT), a classic psychedelic compound that produces acute, time-limited, psychedelic effects. VLS-01 is differentiated from other classic psychedelics by its short half-life and short duration of psychedelic subjective experience (approximately 90-120 minutes).
Clinical evidence supports the therapeutic potential of DMT as a rapid-acting antidepressant.
Purpose and Description
To determine the efficacy of VLS-01-BU compared with placebo in improving depressive symptoms in participants with TRD.
The study includes a placebo-controlled treatment period, a 12-week placebo-controlled follow-up period, and a non-placebo-controlled treatment and follow-up period.
- Screening Visit & Eligibility Review
(2 visits) - Three (3) Dosing Sessions
- Three (3) in-person follow-up visits
- Six (6) follow-up visits (virtual or in-person options)
- End of Treatment visit
Important Considerations
- The study’s procedures and therapy are at no cost to the participant.
- Eligible participants will be randomized 1:1 into the VLS-01-BU or placebo study arm for two dosing sessions. Following the placebo-controlled portion of the treatment, participants will be randomized to receive a single dose of either 120 mg or 60 mg VLS-01-BU. All study activities will be double-blinded. All eligible participants will receive at least 1 dose of VLS-01-BU.
- Study drugs will be administered in private, specifically designed rooms, with physicians and medical staff present on site and constant support from trained and experienced mental-health practitioners.
- Eligible participants will taper off of, or discontinue from, all antidepressants as part of their participation in the study. This plan is created with study physician approval and participant safety is monitored. Participants MUST NOT discontinue ANY medication without the physician’s approval. If necessary, the study physician will consult with patients’ providers.
- Participants should not be pregnant, nursing or planning a pregnancy, and must agree to use a highly effective method of birth control during the entire course of the clinical trial.
- Risks to participation will be reviewed extensively during the screening and informed consent process.Certain medical conditions may be exclusionary and not all participants may be eligible for the study.
- All in person visits take place at Sunstone Therapies. Several visits throughout the study are conducted virtually.
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