PsilOCD: A Pharmacological-Challenge Feasibility Study

NCT06258031 | Completed Phase 1 FDA Drug

• 1 other identifier: 298206
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (2)

• Intradimensional-extradimensional (ID-ED) set shift

  Scores on this neurocognitive task administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB). ID-ED performance is an established measure of cognitive inflexibility in OCD (Chamberlain et al., Am J Psychiatry, 2007), with worse scores corresponding to decreased flexibility.

  4 weeks

• The visual long-term potentiation (vLTP) electroencephalogram (EEG) paradigm (acute quantified changes in neuroplasticity in the visual system).

  We will assess acute changes in homosynaptic neuroplasticity using the visual long-term potentiation (vLYTP) EEG paradigm. In this paradigm, we induce neural plasticity in the occipital cortex by exposing participants to visual stimuli of varying frequencies. This task specifically quantifies homosynaptic plasticity because it triggers changes in neighbouring neurons within the occipital cortex.

  8 weeks

Secondary Outcomes (11)

• Clinical measures of compulsivity of relevance to OCD including Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  8 weeks

• Cognitive measure: Reversal learning task (administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB))

  4 weeks

• Cognitive measure: Information-seeking task

  4 weeks

• Cognitive measure: Visuospatial memory paired-associates learning task (administered as part of the Cambridge Neuropsychological Test Automated Battery (CANTAB))

  4 weeks

• Measures of the acute psychological effects of psilocybin including the Emotional Breakthrough Inventory

  4 weeks

Study Arms (1)

All participants

EXPERIMENTAL

Up to 10mg of psilocybin on two separate dosing days (separated by 4 weeks)

Drug: Psilocybin (COMP360)

Interventions

Psilocybin (COMP360) DRUG

Up to 10mg on two occasions

Also known as: O-phosphoryl-4-hydroxy-N,N-dimethyltryptamine

All participants

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 20 to 65 years;
• Any gender;
• A primary diagnosis of OCD (based on the Mini-International Neuropsychiatric Interview (M.I.N.I.));
• Has met diagnostic criteria for OCD for at least 12 months;
• Willing to comply with protocol and associated lifestyle restrictions;
• Adequate understanding of the English language to give informed consent and participate in the study;
• Participant can attend visits as an outpatient;
• Comfortable using a computer, access to internet from home, and willing to participate in some of the study visits via video-link.

You may not qualify if:

• Current or past history of dependent (according to ICD10 criteria) substance use (not including nicotine and/or caffeine), Tourette's syndrome, autism spectrum disorder, epilepsy, organic mental disorder, or a personality disorder apart from obsessive-compulsive personality disorder;
• Current or past history of psychosis or mania in themselves or a first-degree relative;
• Unstable physical health;
• Significantly abnormal clinical test result;
• Heavy smoker, or unable to attend the dosing days (including the subsequent recovery part) without a smoking break;
• Unwillingness to allow their GP or mental health practitioners to be informed of their participation (or, to allow study team access to Summary Care Record).

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

CIPPRes Clinic

London, W10 6DZ, United Kingdom

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Professor David Nutt

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Dr David Erritzoe

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Dr Luca Pellegrini

  University of Hertfordshire/Imperial College London

  PRINCIPAL INVESTIGATOR

• Professor Naomi Fineberg

  University of Hertfordshire

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Study is single group, but participants are blinded to the fixed doses received on both dosing days (Dose A and Dose B), and the outcomes assessor responsible for evaluating OCD and depression symptoms using the Y-BOCS and MADRS is also blinded. Assessors evaluating all other outcomes are unblinded. Note to editor: I ticked 'None (Open Label)' as advised, to avoid this being flagged and to be able to release this protocol; it is impossible to accurately describe our study's design with these options available. Please may this 'None (Open Label)' description be removed once it is published?
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two different, fixed doses of psilocybin (Dose A = 10mg - x, Dose B = 10mg - y) are given on two separate dosing days to all patients.

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: February 14, 2024
• Study Start: October 28, 2022
• Primary Completion: June 28, 2024
• Study Completion: July 24, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)