Study Summary
This study will test the feasibility, safety, and evidence for efficacy of psilocybin administration in participants with obsessive compulsive disorder (OCD). This will serve as a preliminary proof of concept study for future larger studies aimed to investigate the utility, cognitive mechanisms, and neural correlates of this intervention.
Eligible Conditions
- Obsessive-Compulsive Disorder
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: 1 month post session 2
Month 1
Mental Depression
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Anxiety
Week 1
Change in The Yale Brown Obsessive Compulsive Scale (Y-BOCS) score
Trial Safety
Safety Progress
Side Effects for
Psilocybin
44%Headache
21%Nausea
15%Anxiety
8%Suicidal Ideation
6%Depressed mood
6%Insomnia
4%Vomiting
4%Corona virus infection
4%Alcohol poisoning
4%Viral upper resp. tract infection
4%Pneumonia
4%Depression
4%Upper respiratory tract infection
4%Abdominal pain upper
2%Testicular pain
2%Limb injury
2%Biopsy cervix
2%Dysphoria
2%Oropharyngeal pain
2%Dyspepsia
2%Food allergy
2%Alcohol withdrawal syndrome
2%Pain
2%Influenza
2%Muscle strain
2%Musculoskeletal pain
2%Dizziness
2%Illusion
2%Nasal congestion
2%Skin cosmetic procedure
2%Psychomotor hyperactivity
2%Blood pressure diastolic increased
2%Fatigue
2%Urinary incontinence
2%Asthenia
2%Palpitations
2%Abdominal pain
2%Food poisoning
2%Photopsia
2%Cataract
2%Toothache
2%Back pain
2%Blood pressure increased
2%Myalgia
2%Gingivitis
2%Diverticulitis
2%Hyperventilation
2%Dyspnea
Trial Design
2 Treatment Groups
Delayed Psilocybin
1 of 2
Immediate Psilocybin
1 of 2
Active Control
Experimental Treatment
30 Total Participants · 2 Treatment Groups
Primary Treatment: Immediate Psilocybin · No Placebo Group · Phase < 1
Immediate Psilocybin
Drug
Experimental Group · 1 Intervention: Psilocybin · Intervention Types: DrugDelayed Psilocybin
Drug
ActiveComparator Group · 1 Intervention: Psilocybin · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~560
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 month post session 2
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,017,195 Total Patients Enrolled
Roland R Griffiths, PhDPrincipal InvestigatorJohns Hopkins University
3 Previous Clinical Trials
140 Total Patients Enrolled
Eligibility Criteria
Age 21 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have given informed consent.
You have no antidepressant medications for approximately five half-lives prior to study enrollment.
You are of childbearing potential and sexually active
You are judged by study team clinicians to be at low risk for suicide.
Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.
Who else is applying?
What state do they live in?
| Maryland | 33.3% |
| New Jersey | 33.3% |
| California | 33.3% |
What site did they apply to?
| Johns Hopkins University School of Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I have tried many forms of treatment and still struggle (therapy, medication, alternative medication, EMDR, etc)."
What questions have other patients asked about this trial?
- "How long do screening visits take? How does compensation work?"
How many prior treatments have patients received?
| 0 | 100.0% |
References
- Gillan CM, Kalanthroff E, Evans M, Weingarden HM, Jacoby RJ, Gershkovich M, Snorrason I, Campeas R, Cervoni C, Crimarco NC, Sokol Y, Garnaat SL, McLaughlin NCR, Phelps EA, Pinto A, Boisseau CL, Wilhelm S, Daw ND, Simpson HB. Comparison of the Association Between Goal-Directed Planning and Self-reported Compulsivity vs Obsessive-Compulsive Disorder Diagnosis. JAMA Psychiatry. 2020 Jan 1;77(1):77-85. doi: 10.1001/jamapsychiatry.2019.2998. Erratum in: JAMA Psychiatry. 2019 Nov 20;:.
- John, O. P., Naumann, L. P., & Soto, C. J. (2008). Paradigm shift to the integrative Big Five trait taxonomy: History, measurement, and conceptual issues. Handbook of Personality: Theory and Research, 3rd Ed., 114.
- Guy, W. (1976). ECDEU assessment manual for psychopharmacology-revised (DHEW publ no ADM 76-338). rockville, MD, US department of health, education, and welfare. Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, NIMH Psychopharmacology Research Branch, Division of Extramural Research Programs, 1076, 534-537.
- Goodman, Wayne K.. 1989. “The Yale-brown Obsessive Compulsive Scale”. Archives of General Psychiatry. American Medical Association (AMA). doi:10.1001/archpsyc.1989.01810110048007.
- Beck, A.T., Steer, R.A. and Brown, G.K. (1996) Beck Depression Inventory-II. San Antonio, 78, 490-498.
- Spilberger, C. (1983). Manual for the state-trait anxiety inventory: STAI (Form Y). Palo Alto.
- Doss MK, Weafer J, Gallo DA, de Wit H. Δ(9)-Tetrahydrocannabinol at Retrieval Drives False Recollection of Neutral and Emotional Memories. Biol Psychiatry. 2018 Nov 15;84(10):743-750. doi: 10.1016/j.biopsych.2018.04.020. Epub 2018 May 9.
- Doss MK, Weafer J, Gallo DA, de Wit H. MDMA Impairs Both the Encoding and Retrieval of Emotional Recollections. Neuropsychopharmacology. 2018 Mar;43(4):791-800. doi: 10.1038/npp.2017.171. Epub 2017 Aug 21.
- Demyttenaere, Koen, Henning Friis Andersen, and Elin Heldbo Reines. 2008. “Impact of Escitalopram Treatment on Quality of Life Enjoyment and Satisfaction Questionnaire Scores in Major Depressive Disorder and Generalized Anxiety Disorder”. International Clinical Psychopharmacology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/yic.0b013e328303ac5f.
- Marton T, Samuels J, Nestadt P, Krasnow J, Wang Y, Shuler M, Kamath V, Chib VS, Bakker A, Nestadt G. Validating a dimension of doubt in decision-making: A proposed endophenotype for obsessive-compulsive disorder. PLoS One. 2019 Jun 13;14(6):e0218182. doi: 10.1371/journal.pone.0218182. eCollection 2019.
- Gründler TO, Cavanagh JF, Figueroa CM, Frank MJ, Allen JJ. Task-related dissociation in ERN amplitude as a function of obsessive-compulsive symptoms. Neuropsychologia. 2009 Jul;47(8-9):1978-87. doi: 10.1016/j.neuropsychologia.2009.03.010. Epub 2009 Mar 17.
- Riesel A, Goldhahn S, Kathmann N. Hyperactive performance monitoring as a transdiagnostic marker: Results from health anxiety in comparison to obsessive-compulsive disorder. Neuropsychologia. 2017 Feb;96:1-8. doi: 10.1016/j.neuropsychologia.2016.12.029. Epub 2016 Dec 29.
- Daw ND, Gershman SJ, Seymour B, Dayan P, Dolan RJ. Model-based influences on humans' choices and striatal prediction errors. Neuron. 2011 Mar 24;69(6):1204-15. doi: 10.1016/j.neuron.2011.02.027.
- WARE, JOHN E., JR., MARK KOSINSKI, and SUSAN D. KELLER. 1996. “A 12-item Short-form Health Survey”. Medical Care. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00005650-199603000-00003.
- Banca P, Vestergaard MD, Rankov V, Baek K, Mitchell S, Lapa T, Castelo-Branco M, Voon V. Evidence accumulation in obsessive-compulsive disorder: the role of uncertainty and monetary reward on perceptual decision-making thresholds. Neuropsychopharmacology. 2015 Mar 13;40(5):1192-202. doi: 10.1038/npp.2014.303.
- Doss MK, Weafer J, Gallo DA, de Wit H. Delta9-Tetrahydrocannabinol at Retrieval Drives False Recollection of Neutral and Emotional Memories. Biol Psychiatry. 2018 Nov 15;84(10):743-750. doi: 10.1016/j.biopsych.2018.04.020. Epub 2018 May 9.
- Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Gillan CM, Kalanthroff E, Evans M, Weingarden HM, Jacoby RJ, Gershkovich M, Snorrason I, Campeas R, Cervoni C, Crimarco NC, Sokol Y, Garnaat SL, McLaughlin NCR, Phelps EA, Pinto A, Boisseau CL, Wilhelm S, Daw ND, Simpson HB. Comparison of the Association Between Goal-Directed Planning and Self-reported Compulsivity vs Obsessive-Compulsive Disorder Diagnosis. JAMA Psychiatry. 2020 Jan 1;77(1):77-85. doi: 10.1001/jamapsychiatry.2019.2998. Erratum In: JAMA Psychiatry. 2019 Nov 20;:
- Grundler TO, Cavanagh JF, Figueroa CM, Frank MJ, Allen JJ. Task-related dissociation in ERN amplitude as a function of obsessive-compulsive symptoms. Neuropsychologia. 2009 Jul;47(8-9):1978-87. doi: 10.1016/j.neuropsychologia.2009.03.010. Epub 2009 Mar 17.
- 2022. "Effects of Psilocybin in Obsessive Compulsive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05546658.
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