This is a phase 2a clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks).

Fifty adults ages 18-70 with GAD will undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility. If eligible, they will enter a 4-week open-label Run-in Phase during which they will receive 3 mg/day of psilocybin at have weekly clinic visits. After 4 weeks, those considered treatment responders (≥50% reduction in GAD-7 score from baseline) will be randomized 1:1 to receive either psilocybin oral solution or placebo for another 4 weeks. Other outcome measures include improvements in mood, quality of life, cognitive functioning, biomarkers of treatment response (EEG) and presence/severity of adverse events. The Principal Investigator of this study is Dr. Claudio Soares.

ClinicalTrials.gov ID: NCT06969170

Contact: Yan Deng, MSc, RP

Phone: 1-613-548-3232

Email: yan.deng@queensu.ca

This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled trial assessing the efficacy, safety, and tolerability of repeated doses of VLS-01 Buccal Film for individuals with treatment-resistant depression. VLS-01-BU contains N, N-dimethyltryptamine (DMT), a compound found in ayahuasca. We aim to evaluate the effectiveness of this rapid-onset delivery system to improve tolerability and maintain treatment efficacy. For that, we will assess the efficacy and tolerability after 4 weeks of treatment (2 dosing sessions) of DMT (VLS-01-BU) compared with placebo. The Principal Investigator of this study is Dr. Claudio Soares.

Contact: Pilar Vazquez, Study Coordinator

Phone:  613-544-4900 ext. 52035

Email: vazquezp@providencecare.ca