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Psilocybin-assisted psychotherapy for treatment-resistant obsessive-compulsive disorder: protocol for an open-label
Nicole Ledwos1, Jenna Baer2,3, Muhammad Ishrat Husain2,3,4
1General Adult Psychiatry and Health Systems Division, https://ror.org/03e71c577Centre for Addiction and Mental Health, Toronto, Ontario, Canada.
Psilocybin-assisted psychotherapy shows promise for treatment-resistant obsessive-compulsive disorder (OCD). This study assesses its safety, efficacy, and neurobiological mechanisms, paving the way for larger clinical trials.
Area of Science:
- Neuroscience
- Psychiatry
- Pharmacology
Background:
- Obsessive-compulsive disorder (OCD) affects many individuals, with a significant portion unresponsive to standard treatments like SSRIs and CBT.
- Psilocybin-assisted psychotherapy (PAP) is an emerging intervention for treatment-resistant OCD, necessitating research into its underlying mechanisms.
Purpose of the Study:
- To evaluate the feasibility, tolerability, and safety of PAP in adults with treatment-resistant OCD.
- To gather preliminary clinical efficacy data for PAP in treatment-resistant OCD to guide future large-scale trials.
- To investigate neuroimaging and neurophysiological changes before and after PAP in treatment-resistant OCD patients.
Main Methods:
- A 12-week open-label trial involving ten adults with treatment-resistant OCD receiving a single 25 mg dose of psilocybin with psychological support.
- Feasibility, tolerability, and safety assessed throughout the trial.
- Clinical outcomes measured using the Yale-Brown Obsessive-Compulsive Scale, with exploratory neuroimaging (dynamic connectivity), electroencephalogram, and TMS-EEG analyses.
Main Results:
- Preliminary data on the feasibility and efficacy of PAP in treatment-resistant OCD.
- Insights into the neurobiological mechanisms associated with PAP's effects on OCD symptoms.
Conclusions:
- Findings will inform the design of larger, randomized controlled trials for PAP in OCD.
- This research contributes to advancing the field of psychedelic-assisted therapies for mental health conditions.
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