Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 6, 2025

Primary Completion Date

June 1, 2026

Study Completion Date

August 30, 2026

Conditions
Generalized Anxiety Disorder (GAD)
Interventions
DRUG

Psilocybin (drug)

Psilocybin 3mg Po (oral solution) administered daily for 28 days (Open-Label Run-in Phase) followed by Psilocybin 3mg Po (oral solution) OR Placebo for 28 days (Double-Blind Treatment Phase) in patients with Generalized Anxiety Disorder(GAD)

OTHER

Placebo

Sucralose 0.2% oral solution

Trial Locations (1)

K7L 2V7

RECRUITING

Kingston General Health Research Institute, Kingston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Diamond Therapeutics Inc.

INDUSTRY

collaborator

Kingston Health Sciences Centre

OTHER

lead

Queen's University

OTHER