NCT06258031

PsilOCD: A Pharmacological-Challenge Feasibility Study

PsilOCD: Evaluating the Effects of the 5-HT2A Agonist Psilocybin on the Neurocognitive and Clinical Correlates of Compulsivity (A Pharmacological-Challenge Feasibility Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DRUG	Psilocybin (COMP360)	Up to 10mg on two occasions

Timeline

• Start date: 2022-10-28
• Primary completion: 2024-06-28
• Completion: 2024-07-24
• First posted: 2024-02-14
• Last updated: 2024-11-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study