PsilOCD: A Pharmacological-Challenge Feasibility Study

This single-group assignment trial (n=20) assesses the impact of psilocybin (10mg, 2x) on cognitive inflexibility and neural plasticity in individuals with obsessive-compulsive disorder (OCD).

Participants, aged between 20 to 65 years, diagnosed with OCD according to DSM-5 criteria, will receive up to 10mg of psilocybin on two separate dosing days spaced four weeks apart. The dosing will occur under medical supervision with psychological support from experienced therapists. Before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. Cognitive tasks will be administered in the days following each dosing session, along with acute post-dosing EEG recordings and blood samples. OCD symptoms will also be assessed periodically throughout the trial by an external blinded psychiatrist.

This interventional study is led by Imperial College London and commenced on October 28, 2022. The primary completion is estimated by June 30, 2024, with the study completion estimated by July 30, 2024. It aims to enrol 20 participants and is part of Phase I clinical trials.

Topic Obsessive-Compulsive Disorder
Compound Psilocybin
Country United Kingdom
Visit trial
Status Recruiting
Results Published No
Start date 28 October 2022
End date 30 July 2024
Phase Phase I
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 20- 65
Therapy Yes

Trial Details

The purpose of this study is to assess the impact of psilocybin on cognitive inflexibility and neural plasticity in a cohort of people with obsessive-compulsive disorder (OCD). This mechanistic study will utilise a within-subjects design, administering up to 10mg of psilocybin to participants with OCD (DSM-5 criteria) on two separate instances spaced four weeks apart. To ensure consistency and participant safety, dosing will occur under medical supervision with psychological support from two experienced therapists. Before and after each session, participants will engage in virtual preparation and integration sessions led by their therapists. Cognitive tasks will be administered in the days following each dosing session. Additionally, acute post-dosing EEG recordings will be conducted, and blood samples will be taken after each dosing session. OCD symptoms will also be assessed seven times throughout the trial by an external blinded psychiatrist, serving as a secondary outcome. Collectively, these measures aim to evaluate changes in cognitive inflexibility, decision-making abilities, neuroplasticity (peripheral blood markers and EEG measures), inflammation (peripheral blood markers), and symptomatology following each dosing session.

NCT Number NCT06258031

Sponsors & Collaborators

Imperial College London
The Centre for Psychedelic Research studies the action (in the brain) and clinical use of psychedelics, with a focus on depression.

Data attribution

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