Feasibility, Clinical Effects, and Safety of... — Clinical Trial Details

Proof-of-concept, open-label single-group trial of 10 adults with treatment-resistant OCD receiving two 25 mg oral psilocybin sessions two weeks apart with psychological support; primary aims are safety and feasibility with Y-BOCS change at Week 3 as a key clinical outcome.

Dosing sessions occur in CAMH’s psychedelic treatment suite, last approximately 5–6 hours, and are supported by two trained therapists; psilocybin is encapsulated (HPMC, PEX010) and participants are discharged with a caregiver after safety evaluation.

Screening includes SCID-5, labs and medication tapering as needed; assessments include Y-BOCS, C-SSRS, AE monitoring, fMRI and neurophysiological measures with follow-ups through 12 weeks after second dosing.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

Adults 18 to 65 years old;
Are outpatients;
Must be deemed to have capacity to provide informed consent;
Must sign and date the informed consent form;
Stated willingness to comply with all study procedures;
Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;
Primary DSM-5 diagnosis of obsessive compulsive disorder (OCD) based on medical records and assessment using the SCID-5 administered at the first screening visit;
Participants diagnosed with treatment-resistant OCD defined as individuals with a score of ≥ 16 on the YBOCS and who have not responded to two or more separate pharmacological interventions and one or more trials of cognitive behavioural therapy (CBT);
Individuals with an estimated glomerular filtration rate (eGFR) above 40 mL/min/1.73 m2 and all blood work within normal limits as assessed by clinical laboratory tests at Screening (V1);
Ability to take oral medication;
Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;
Individuals who are willing to and have tapered off current OCD medications for a minimum of 2 weeks prior to Baseline (V2) and whose physician confirms that it is safe for them to do so;
Individuals who are willing to and have tapered off current inhibitors of UGT1A9 and UGT1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of 2 weeks prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so;
Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria

Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individuals that intend to become pregnant during the study or are breastfeeding;
Treatment with another investigational drug or other intervention within 30 days of Screening (V1);
Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);
Have a DSM-5 diagnosis of substance use disorder (use of tobacco and prescribed opioids are permitted) within the preceding 6 months;
Have active suicidal ideation as determined by the C-SSRS and/or clinical interview. Significant suicide risk is defined by suicidal ideation as endorsed by items 4 or 5 of the C-SSRS;
Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;
Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;
Have contraindications to transcranial magnetic stimulation (TMS) as determined by the TASS questionnaire;
Have a history of seizures;
Are taking anticonvulsants or benzodiazepines (Lorazepam up to 2 mg/day is acceptable);
Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmia, severe coronary artery disease, or moderate to severe renal or hepatic impairment;
Use of classic psychedelic drugs within the previous 12 months;
Any other clinically significant physical illness that may interfere with interpretation of the study results or constitute a health risk for the participant.

Company

Product

Legal

Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD (PAP-OCD)

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin 25 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators