Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD
- Conditions
- Obsessive-Compulsive Disorder
- Registration Number
- NCT06299319
- Lead Sponsor
- Centre for Addiction and Mental Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Adults 18 to 65 years old;<br><br> - Are outpatients<br><br> - Must be deemed to have capacity to provide informed consent;<br><br> - Must sign and date the informed consent form;<br><br> - Stated willingness to comply with all study procedures;<br><br> - Ability to read and communicate in English, such that their literacy and<br> comprehension is sufficient for understanding the consent form and study<br> questionnaires, as evaluated by study staff obtaining consent;<br><br> - Primary The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition<br> (DSM-5) diagnosis of obsessive compulsive disorder (OCD) based on medical records<br> and assessment using the Structured Clinical Interview for DSM-5 (SCID-5)<br> administered at the first screening visit;<br><br> - Participants diagnosed with treatment-resistant OCD defined as individuals with a<br> score of = 16 on the YBOCS (i.e. moderate symptom severity) and that have not<br> responded to two or more separate pharmacological interventions and one or more<br> trials of cognitive behavioural therapy (CBT); there is no upper limit on the number<br> of treatment failures;<br><br> - Individuals with an estimated glomerular filtration rate (eGFR) above<br> 40mL/min/1.73m2 and all blood work within normal limits as assessed by clinical<br> laboratory tests at Screening (V1)<br><br> - Ability to take oral medication;<br><br> - Individuals who are capable of becoming pregnant: use of highly effective<br> contraception for at least 1 month prior to screening and agreement to use such a<br> method during study participation;<br><br> - Individuals who are willing to and have tapered off current OCD medications for a<br> minimum of 2-weeks prior to Baseline (V2) and whose physician confirms that it is<br> safe for them to do so;<br><br> - Individuals who are willing to and have tapered off current inhibitors of<br> 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase<br> inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of<br> 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the<br> duration of the study and whose physician confirms that it is safe for them to do<br> so; and<br><br> - Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study<br> duration.<br><br>Exclusion Criteria:<br><br> - Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2)<br> or individuals that intend to become pregnant during the study or are breastfeeding;<br><br> - Treatment with another investigational drug or other intervention within 30 days of<br> Screening (V1);<br><br> - Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);<br><br> - Have a DSM-5 diagnosis of substance use disorder (use of tobacco and prescribed<br> opioids are permitted) within the preceding 6 months;<br><br> - Have active suicidal ideation as determined by the C-SSRS and/or clinical interview.<br> Significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5<br> of the C-SSRS;<br><br> - Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; psychotic<br> disorder (unless substance induced or due to a medical condition), bipolar I or II<br> disorder, paranoid personality disorder, borderline personality disorder, or<br> neurocognitive disorder as determined by medical history and the SCID-5 clinical<br> interview;<br><br> - Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder;<br> psychotic disorder (unless substance-induced or due to a medical condition); or<br> bipolar I or II disorder as determined by the family medical history form and<br> discussions with the participant;<br><br> - Have contraindications to transcranial magnetic stimulation (TMS) as determined by<br> the transcranial magnetic stimulation adult safety screen (TASS) questionnaire;<br><br> - Have a history of seizures;<br><br> - Are taking anticonvulsants or benzodiazepines (Lorazepam up to 2mg/day is<br> acceptable);<br><br> - Presence of a relative or absolute contraindication to psilocybin, including a drug<br> allergy, recent stroke history, uncontrolled hypertension, low or labile blood<br> pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery<br> disease, or moderate to severe renal or hepatic impairment;<br><br> - Use of classic psychedelic drugs within the previous 12 months; OR<br><br> - Any other clinically significant physical illness including chronic infectious<br> diseases or any other major concurrent illness that, in the opinion of the<br> investigator, may interfere with the interpretation of the study results or<br> constitute a health risk for the participant if they take part in the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of administering psilocybin (25 mg) in adults with treatment-resistant OCD;Incidence of adverse events (Safety and Tolerability);Change in the Yale-Brown Obsessive-Compulsive Scale (YBOCS) total score from baseline
- Secondary Outcome Measures
Name Time Method Proportion of participants who respond to treatment;Changes in Patient Health Questionnaire (PHQ-9) from Baseline to Week 3;Change in the Clinical Global Impression (CGI) scale from Baseline to Week 3;Change in the World Health Organization Quality of Life Short Version (WHOQOL-BREF) score from Baseline to Week 3;Change in World Health Organization Disability Assessment Schedule (WHODAS 2.0) from Baseline to Week 3;Change in Generalized Anxiety Disorder (GAD-7) scores from Baseline to Week 3;Changes in behavioural assessments for well-being (Warwick-Edinburgh Mental Wellbeing Scale; WEMWBS) from Baseline to Week 3