Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD (PAP-OCD)

This open-label clinical trial (n=10) evaluates the feasibility, clinical effects, and safety of psilocybin-assisted psychotherapy (25mg, 2x) for treatment-resistant obsessive-compulsive disorder (OCD).

Participants, aged 18 to 65, diagnosed with treatment-resistant OCD, will receive two doses of 25mg of psilocybin, two weeks apart, alongside supportive therapy.

The study aims to recruit and retain participants with TROCD and assess the safety of psilocybin-assisted psychotherapy, measured by adverse events and the Columbia Suicide Severity Rating Scale. Additionally, the trial will measure changes in OCD symptoms using the Yale-Brown Obsessive Compulsive Scale (YBOCS) and evaluate secondary outcomes such as treatment response, depression severity, and quality of life.

The study is conducted by the Centre for Addiction and Mental Health (CAMH) and will run from April 2024 to September 2024.

Topic Obsessive-Compulsive Disorder Depression Safety
Compound Psilocybin
Country Canada
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 April 2024
End date 30 September 2024
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 10
Sex All
Age 18- 65
Therapy Yes

Trial Details

Psilocybin, the chemical component of "magic mushrooms", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the safety, feasibility, and clinical effects of psilocybin administration in those with OCD. Ten participants with treatment-resistant OCD will receive two doses of 25mg of psilocybin under supportive conditions, two weeks apart. The investigators hypothesize that two sessions of psilocybin 25mg administered under supportive conditions to participants with treatment-resistant OCD will lead to significant reductions in OCD symptoms.

NCT Number NCT06299319

Data attribution

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