protocolSection identificationModule nctId: NCT06299319, orgStudyIdInfo id: 149-2021, briefTitle: Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD, acronym: PAP-OCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-09, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Centre for Addiction and Mental Health, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Obsessive-Compulsive Disorder, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Psilocybin, outcomesModule primaryOutcomes measure: Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD, primaryOutcomes measure: Incidence of adverse events (Safety and Tolerability), primaryOutcomes measure: Change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score from baseline, secondaryOutcomes measure: Proportion of participants who respond to treatment, secondaryOutcomes measure: Changes in Patient Health Questionnaire (PHQ-9) from Baseline to Week 3, secondaryOutcomes measure: Change in the Clinical Global Impression (CGI) scale from Baseline to Week 3, secondaryOutcomes measure: Change in the World Health Organization Quality of Life Short Version (WHOQOL-BREF) score from Baseline to Week 3, secondaryOutcomes measure: Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) from Baseline to Week 3, secondaryOutcomes measure: Change in Generalized Anxiety Disorder (GAD-7) scores from Baseline to Week 3, secondaryOutcomes measure: Changes in behavioural assessments for well-being (Warwick-Edinburgh Mental Wellbeing Scale; WEMWBS) from Baseline to Week 3, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-10-20, uploadDate: 2024-02-14T17:40, filename: Prot_SAP_000.pdf, size: 879497, hasResults: False