Developing Optimal Psychedelic Assisted Psychotherapy for Obsessive-Compulsive Disorder

Phase 2

Recruiting

• Conditions: Treatment Resistant Obsessive-Compulsive Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622001525774
• Lead Sponsor: Australian National University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-09
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diagnosis of Obsessive-Compulsive Disorder, in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5)

18-65 years of age.

Treatment resistant symptoms:
For OCD: failure to tolerate or respond to at least 2 trials of adequate medication therapy (SSRI or clomipramine) at minimum effective therapeutic dose for at least 8 weeks
Moderate – severe symptoms:
For OCD: YBOCS score of >13

Demonstrated capacity to give informed consent

Willingness and capacity (as judged on assessment by study clinicians) to engage in the therapeutic elements of the study protocol

Exclusion Criteria

Participants who are not able to give adequate informed consent.

Current or previously diagnosed psychotic disorder, schizophrenia or bipolar disorder

Immediate family member with a diagnosed psychotic disorder

Significant history of mania.

Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure)

History of serious suicide attempts in recent years requiring hospitalisation as judged by a study psychiatrist at initial assessment to impact on safety of participation.

Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin / MDMA, e.g., borderline personality disorder

Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding.

Participants who do not agree to use an acceptable contraceptive method throughout their participation in the study.

Current drug or alcohol dependence

Recreational use in last 12 months of psychedelic substances or a history of regular psychedelic use

No email access/ability or no willingness to engage in follow up by electronic questionnaires

Use of contraindicated medication (outlined further below) including MAOI, SSRI or SNRI: SSRI/SNRI withdrawal for at least one week (4 weeks for fluoxetine), 2 weeks for irreversible MAOI

Use within 5 half-lives of any other serotonin-enhancing medication

Participants presenting with abnormal QT interval prolongation at screening or with a history of this (QTc at screening above 440ms for men and above 470ms for women)

Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.

Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.

BMI <17 or >42

Participants with significant difficulties in English comprehension or communication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score on the Yale-Brown Obsessive-Compulsive Scale (YBOCS).[ Baseline compared to study timepoints: Post Drug therapy session 1, Post Drug therapy session 2, Post Drug therapy session 3, End Integration Therapy (8 weeks post-baseline) (primary timepoint), and 1, 3 and 6 months post-integration therapy completion]