Developing Optimal Psychedelic Assisted Psychotherapy for Obsessive-Compulsive Disorder

This interventional trial (n=40) seeks to explore the potential for psychedelic therapy using psilocybin and MDMA to improve symptoms of treatment-resistant obsessive-compulsive disorder (TR-OCD). Registered on ANZCTR with the acronym OPT-PAP, the trial is ethically approved and prospectively registered.

Participants aged 25-65 diagnosed with TR-OCD will be randomly assigned to two groups, receiving either MDMA + Exposure Response Prevention Intervention or Psilocybin + ACT Intervention. The trial involves a series of preparation and integration therapy sessions and three drug administration sessions over an eight-week period.

Primary outcomes, measured using the Yale-Brown Obsessive-Compulsive Scale (YBOCS), will be assessed at various time points, including post-drug therapy sessions, end integration therapy (8 weeks post-baseline), and 1, 3, and 6 months post-integration therapy completion. Secondary outcomes include measures of depression, anxiety, quality of life, and various cognitive assessments.

Led by the Monarch Mental Health Group, funded by the Australian National University, and conducted at Clerkenwell Health, UK, the trial aims to provide insights into the effectiveness, acceptability, and tolerability of psychedelic therapy for TR-OCD, along with potential changes in brain activity associated with MDMA and psilocybin exposure. The principal investigator is Prof Paul Fitzgerald, and the trial is anticipated to run from January 2023 to October 2024.

Topic Obsessive-Compulsive Disorder
Compound Psilocybin MDMA
Country Australia United Kingdom
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 August 2023
End date 30 October 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
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

Sponsors & Collaborators

Clerkenwell Health
Clerkenwell is a clinical research organisation (CRO) in the UK that supports drug developers as they attempt to commercialise psychedelic therapies. Clerkenwell offers support from preclinical studies up to Phase III of the drug development process.

Data attribution

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