Safety and efficacy of psilocybin-assisted psychotherapy for Generalised Anxiety Disorder [Psi-GAD-1]: a randomised triple-blind active-placebo-controlled trial

This trial (n=72) will investigate the effects of psilocybin (2x, 25/30mg) versus an active placebo (diphenhydramine) in patients with generalised anxiety disorder (GAD). The trial will be one of the largest to date in Australia.

Topic Anxiety
Compound Psilocybin Placebo
Country Australia
Visit trial
Status Recruiting
Results Published No
Start date 10 January 2022
End date 31 December 2023
Chance of happening 99%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 70
Sex All
Age 18- 75
Therapy Yes

Trial Details

Psilocybin-assisted psychotherapy has demonstrated excellent safety and efficacy in the treatment of depression, substance use disorders, and mental ill-health related to terminal illness. Many patients in these trials have reported rapid, large, and persistent decreases in symptoms of anxiety, suggesting utility in treating anxiety disorders with psilocybin-assisted psychotherapy. However, the impact of this treatment for people with GAD is unknown. In this study, we will complete a randomised controlled trial to test a 7 week (2 dose) psilocybin-assisted psychotherapy for the treatment of GAD. 72 individuals will be randomly assigned to receive two doses either psilocybin (25mg or 30mg, oral) or placebo (diphenhydramine, 75mg or 100mg, oral) with three weeks between doses. All participants will receive psychotherapy before, during, and after dosing sessions. A variety of measures will test for safety and efficacy of the treatment. The primary outcome measure investigates change in clinician-rated symptoms of anxiety. A range of secondary and exploratory measures probe changes in disability, quality of life, comorbid psychiatric and addictive symptoms, baseline and acute predictors, as well as participant-rated acceptability, appropriateness and feasibility of the treatment.

NCT Number

Sponsors & Collaborators

Monash University
The Clinical Psychedelic Lab, established in 2020, within the Dept Psychiatry at Monash University is the first of its kind in Australia, leading the development and implementation of psychedelic therapies. The lab has played a central role in establishing the field of clinical psychedelic research in Australia.

Incannex Healthcare
Incannex Healthcare is a clinical-stage cannabinoid and psychedelic medicine developer.

Data attribution

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