Study Summary
This trial looks at whether psilocybin, a compound found in some mushrooms, can help relieve symptoms of OCD. They will also study what effects psilocybin has on the brain.
Eligible Conditions
- Obsessive-Compulsive Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 36 Secondary · Reporting Duration: Baseline, 48 hours post-drug, weeks: 1, 2, 4, 12 post-drug
Week 12
Changes in subjects' behaviors and attitudes, which will be measured by The Community Observer Ratings of Changes in Subjects' Behavior and Attitudes (COM-R).
Day 2
Changes of the effects of Psilocybin, which will be measured by The Persisting Effects Questionnaire (PEQ).
24 hours post-drug
Acute Yale-Brown Obsessive-Compulsive Scale (A-YBOCS)
Week 12
Changes in reactions to research participation, measured by the Reactions to Research Participation Questionnaire (RRPQ)
Week 1
Changes in action identification, measured by the Behavior Identification Form (BIF)
Week 12
Changes in OCD symptoms, which will be measured by The Padua Inventory of OCD symptoms.
Changes in alcohol consumption, which will be measured by The Alcohol Use Disorders Identification Test (AUDIT).
Changes in drug-related problems, which will be measured by The Drug Use Disorders Identification Test (DUDIT).
Changes in functional impairment, which will be measured by The Sheehan Disability Scale (SDS).
Changes in optimism and pessimism, which will be measured by The Life Orientation Test Revised (LOT-R).
Changes in symptom severity and treatment response, which will be measured by The Clinical Global Impressions (CGI).
Changes in tobacco use, motivation to quit, and dependence, which will be measured by The Self-reported Nicotine Use (SRNU).
Changes in urgent care and emergency room use, which will be measured by The Utilization of Facility and Emergent Care (UFEC).
Day 2
Changes in Immunological function.
Week 2
Change in interpersonal connectedness, which will be measured by The Inclusion of Others in Self Scale (IOS).
Change in moral relativism and idealism, which will be measured by The Ethical Positions Questionnaire (EPQ).
Changes in OCD dimensions, which will be measured by The Obsessive-Compulsive Trait Core Dimensions Questionnaire (OC-TCDQ).
Changes in OCD symptoms, which will be measured by The Obsessive-Compulsive Inventory - Revised (OCI-R).
Changes in anthropomorphism, which will be measured by The Individual Differences in Anthropomorphism Questionnaire (IDAQ).
Changes in beliefs of mind-body dualism, which will be measured by The Mind-Body Dualism Scale (MBDS).
Changes in connection to nature, which will be measured by The Nature Relatedness Scale (NRS).
Changes in dysfunctional beliefs, which will be measured by The Obsessive Beliefs Questionnaire (OBQ-44).
Changes in opinion towards pro-environmental behavior, which will be measured by The Pro-Environmental Behavior Scale (PEBS).
Hour 48
Changes in brain connectivity, which will be measured with functional Magnetic Imaging Resonance (fMRI).
Day 1
Changes in depression symptoms, which will be measured by The Becks Depression Inventory (BDI).
Changes in depression symptoms, which will be measured by the Beck Depression Inventory (BDI).
Day 2
Changes in anxiety, which will be measured by State-Trait Anxiety Inventory (STAI).
Changes in different dimensions of emotional experience, which will be measured by The Positive and Negative Affect Schedule Expanded Form (PANAS-X).
Day 2
Changes in depression symptoms, which will be measured by The Montgomery-Asberg Depression Scale (MADRS).
Hour 48
Changes in severity of OCD symptoms, measured by Acute Yale-Brown Obsessive-Compulsive Scale (A-YBOCS)
Changes in severity of OCD symptoms, measured by Visual Analog Scale (VAS) for OCD symptoms
Hour 48
Changes in severity of OCD symptoms, which will be measured by The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The Measure will be collected at baseline and 48 hours, assessing change from baseline at 48 hours.
Hour 48
Changes in sleep quality, which will be measured by The Pittsburgh Sleep Quality Index (PSQI).
Hour 48
Changes in readiness to change, which will be measured by The University of Rhode Island Change Assessment (URICA).
Baseline, weeks: 1 & 12 post-drug
Changes in meaning of life, which will be measured by The Schedule for Meaning in Life Evaluation (SMiLE).
Baseline, weeks: 2 & 12 post-drug
Changes in beliefs, which will be measured by The Brown Assessment of Beliefs Scale (BABS).
Changes in quality of life, which will be measured by The Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LESQ-SF).
Day of drug administration
5-Dimension - Altered States of Consciousness (5D-ASC)
Challenging Experience Questionnaire (CEQ)
Day of drug administration, weeks: 2 & 12 post-drug
Changes in experiential aspects of psilocybin, which will be measured by The Mystical Experience Questionnaire (MEQ).
Week 12
Changes in suicidality, measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Psilocybin
1 of 2
Niacin
1 of 2
Experimental Treatment
Non-Treatment Group
30 Total Participants · 2 Treatment Groups
Primary Treatment: Psilocybin (0.25mg/kg) · Has Placebo Group · Phase 1
Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin (0.25mg/kg) · Intervention Types: DrugNiacin
Drug
PlaceboComparator Group · 1 Intervention: Niacin (250mg) · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 48 hours post-drug, weeks: 1, 2, 4, 12 post-drug
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,711 Previous Clinical Trials
20,477,997 Total Patients Enrolled
10 Trials studying Obsessive-Compulsive Disorder
561 Patients Enrolled for Obsessive-Compulsive Disorder
Heffter Research InstituteOTHER
13 Previous Clinical Trials
480 Total Patients Enrolled
Christopher Pittenger, MD, PhDStudy DirectorYale University
2 Previous Clinical Trials
130 Total Patients Enrolled
2 Trials studying Obsessive-Compulsive Disorder
130 Patients Enrolled for Obsessive-Compulsive Disorder
Benjamin Kelmendi, MDPrincipal Investigator - Yale University
Yale University
2 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Obsessive-Compulsive Disorder
30 Patients Enrolled for Obsessive-Compulsive Disorder
Eligibility Criteria
Age 21 - 65 · All Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You cannot take certain psychiatric medications (like antidepressants or antipsychotics) during the study. You also cannot take certain other medications (like those for seizures or heart problems) on the day of treatment.
You have a score of 19 or higher on the Y-BOCS assessment, which measures the severity of obsessive-compulsive disorder symptoms.
You have tried at least one standard treatment for OCD, such as medication or therapy (CBT/ERP), and it was not effective.
Who else is applying?
What state do they live in?
| New York | 23.4% |
| Connecticut | 19.1% |
| New Jersey | 10.6% |
| Other | 46.8% |
How old are they?
| 18 - 65 | 97.6% |
| < 18 | 2.4% |
What site did they apply to?
| Connecticut Mental Health Center | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 97.9% |
| Did not meet criteria | 2.1% |
Why did patients apply to this trial?
- "Promise of psylocibin in OCD"
- "The quality of my life is very poor."
- "I was diagnosed with OCD over 12 years ago. No medications have worked. I am looking for treatment."
How many prior treatments have patients received?
| 0 | 33.3% |
| 1 | 33.3% |
| 3+ | 33.3% |
What questions have other patients asked about this trial?
- "I have had panic attacks; severe as a teenager, infrequent as an adult. If one should experience such an experience, what safeguards are in place to mitigate severity, if panic occurs, during trial?"
How responsive is this trial?
Most responsive sites:
- Connecticut Mental Health Center: < 24 hours
Average response time
- < 2 Days
Typically responds via
| 100.0% | |
References
- Carhart-Harris, Robin L., David Erritzoe, Tim Williams, James M. Stone, Laurence J. Reed, Alessandro Colasanti, Robin J. Tyacke, et al.. 2012. “Neural Correlates of the Psychedelic State as Determined by Fmri Studies with Psilocybin”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1119598109.
- Moreno, Francisco A., Christopher B. Wiegand, E. Keolani Taitano, and Pedro L. Delgado. 2006. “Safety, Tolerability, and Efficacy of Psilocybin in 9 Patients with Obsessive-compulsive Disorder”. The Journal of Clinical Psychiatry. Physicians Postgraduate Press, Inc. doi:10.4088/jcp.v67n1110.
- Griffiths, Roland R, Matthew W Johnson, Michael A Carducci, Annie Umbricht, William A Richards, Brian D Richards, Mary P Cosimano, and Margaret A Klinedinst. 2016. “Psilocybin Produces Substantial and Sustained Decreases in Depression and Anxiety in Patients with Life-threatening Cancer: A Randomized Double-blind Trial”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881116675513.
- Ross, Stephen, Anthony Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara Malone, Barry Cohen, Sarah E Mennenga, et al.. 2016. “Rapid and Sustained Symptom Reduction Following Psilocybin Treatment for Anxiety and Depression in Patients with Life-threatening Cancer: A Randomized Controlled Trial”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881116675512.
- Ross, Stephen, Anthony Bossis, Jeffrey Guss, Gabrielle Agin-Liebes, Tara Malone, Barry Cohen, Sarah E Mennenga, et al.. 2016. “Rapid and Sustained Symptom Reduction Following Psilocybin Treatment for Anxiety and Depression in Patients with Life-threatening Cancer: A Randomized Controlled Trial”. Journal of Psychopharmacology. SAGE Publications. doi:10.1177/0269881116675512.
- Griffiths RR, Johnson MW, Carducci MA, Umbricht A, Richards WA, Richards BD, Cosimano MP, Klinedinst MA. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016 Dec;30(12):1181-1197. doi: 10.1177/0269881116675513.
- Ross S, Bossis A, Guss J, Agin-Liebes G, Malone T, Cohen B, Mennenga SE, Belser A, Kalliontzi K, Babb J, Su Z, Corby P, Schmidt BL. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. J Psychopharmacol. 2016 Dec;30(12):1165-1180. doi: 10.1177/0269881116675512.
- Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006 Nov;67(11):1735-40. doi: 10.4088/jcp.v67n1110.
- Benjamin Kelmendi, MD 2018. "Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03356483.
Frequently Asked Questions
What risks are associated with a 0.25mg/kg dosage of Psilocybin?
"The safety of Psilocybin (0.25mg/kg) is rated a 1, as this clinical trial falls into the Phase 1 stage, meaning there is limited data confirming its efficacy and minimal evidence to suggest it is safe for human consumption." - Anonymous Online Contributor
Unverified Answer
How many participants are being accepted into this experiment?
"Affirmative. According to the clinicaltrials.gov database, this trial is actively recruiting participants and has been since November 13th 2018; its status was last updated on December 7th 2021. Currently, 30 patients are being sought out over 1 location." - Anonymous Online Contributor
Unverified Answer
Who meets the criteria to join this medical experiment?
"In order to be eligible for this clinical trial, candidates must have an OCD diagnosis and fall between 21-65 years old. Approximately 30 individuals are needed in total." - Anonymous Online Contributor
Unverified Answer
Is the enrollment criterion for this research trial restricted to individuals aged 25 or younger?
"The entry qualifications for this medical trial stipulate that potential participants must be 21 or older, while the upper age limit is 65." - Anonymous Online Contributor
Unverified Answer
What medical conditions has research shown Psilocybin (0.25mg/kg) to be most effective in treating?
"Psilocybin (0.25mg/kg) is a reliable option for treating high cardiovascular risk and other issues like dyslipidemia, pancreatitis risks, and lipidemia." - Anonymous Online Contributor
Unverified Answer
Are there vacancies for eligible participants in this clinical trial?
"Clinicaltrials.gov records indicate that this medical trial is open to recruitment and was initially posted on November 13th 2018, with the latest update occurring on December 7th 2021." - Anonymous Online Contributor
Unverified Answer