Developing Optimal Psychedelic Assisted Psychotherapy: Investigating the Effect on Symptom Severity for Adults with Obsessive-Compulsive Disorder

This double-blind, randomised controlled trial (n=40) aims to investigate the efficacy of psychedelic therapy using psilocybin and MDMA in treating treatment-resistant Obsessive-Compulsive Disorder (OCD) in adults.

Led by Prof Paul Fitzgerald from the Australian National University, the study involves a total of 40 participants aged between 25 to 65 years who have been diagnosed with OCD and have shown resistance to conventional treatments.

The trial employs a double-blind methodology, where both participants and raters are unaware of the treatment allocation. Participants will undergo a series of preparation and integration therapy sessions, followed by three drug administration sessions involving either MDMA or psilocybin.

The primary outcome measure will be the total score on the Yale-Brown Obsessive-Compulsive Scale (YBOCS), assessed at various time points throughout the study. Secondary outcomes include measures of depression, anxiety, quality of life, and neurophysiological assessments such as EEG measurements.

The trial, funded by the Monarch Mental Health Group and conducted at the Australian National University, aims to provide insights into the effectiveness, acceptability, and tolerability of psychedelic therapy for OCD, as well as any associated changes in brain activity.

Topic Obsessive-Compulsive Disorder
Compound Psilocybin MDMA
Country Australia
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2023
End date 30 December 2025
Phase Phase II
Design Blinded
Type Interventional
Participants 40
Sex All
Age 25- 65
Therapy Yes

Trial Details

There is increasing evidence that new interventional pharmacotherapies such as psychedelic therapy may be helpful for the treatment of a number of mental health conditions. The purpose of this study is to explore the potential for psychedelic therapy using psilocybin and MDMA to improve symptoms of treatment resistant OCD, and to determine whether there is any pre-post change in electroencephalography (EEG) measurements following psychedelic exposure. To do so, we will carry out a double blind (participant and rater) clinical trial of psilocybin and MDMA assisted psychotherapy in 40 participants (20:20 drug allocation) with treatment resistant OCD. Participants will undergo a series of preparation and integration therapy sessions and 3 drug administration sessions. The results of this study will provide us information about the effectiveness, acceptability, and tolerability of this treatment for this disorder, as well as whether there are any brain activity changes associated with having been exposed to MDMA and psilocybin.

NCT Number ACTRN12622001525774

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.