Your session is about to expire
← Back to Search
Psychedelic
Psilocybin for Obsessive-Compulsive Disorder
Phase 1
Waitlist Available
Led By Benjamin Kelmendi, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Non-consumption of SSRIs for at least 8 weeks at the time of randomization
Primary DSM-5 diagnosis of OCD
Must not have
Unstable neurological or medical condition(s) that may render study procedures unsafe, including poorly managed diabetes, hypertension, or cardiovascular conditions, or history of seizure(s) or chronic/severe headaches
Any history of head injury with loss of consciousness for more than 30 minutes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 48 hours post-drug, weeks: 1, 2, 4, 12 post-drug
Awards & highlights
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.
Who is the study for?
This trial is for adults with Obsessive-Compulsive Disorder (OCD) who have tried at least one standard treatment without success. Participants must not be taking certain psychiatric medications, including SSRIs, and should have a support person available. They cannot join if they have a history of certain mental disorders, recent psychedelic use, or conditions that make MRI scans unsafe.Check my eligibility
What is being tested?
The study tests the impact of psilocybin on OCD symptoms compared to niacin as a placebo. It's double-blind, meaning neither participants nor researchers know who gets the real drug versus placebo during the trial. The goal is to understand how psilocybin might affect brain function related to OCD.See study design
What are the potential side effects?
Psilocybin can cause various side effects such as changes in sensory perception, mood swings, dizziness, nausea, and headaches. In some cases it may lead to anxiety or panic reactions especially in individuals predisposed to these conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't taken SSRIs for at least 8 weeks.
Select...
I have been diagnosed with OCD.
Select...
I stopped taking my SSRI medication long enough for it to be out of my system.
Select...
I have tried at least one standard OCD treatment without success.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled diabetes, high blood pressure, heart issues, or a history of seizures or severe headaches.
Select...
I have had a head injury where I was unconscious for over 30 minutes.
Select...
My Tourette syndrome has not improved.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of drug administration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of drug administration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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.
+1 moreSecondary outcome measures
5-Dimension - Altered States of Consciousness (5D-ASC)
Challenging Experience Questionnaire (CEQ)
Change in interpersonal connectedness, which will be measured by The Inclusion of Others in Self Scale (IOS).
+29 moreOther outcome measures
Changes in Immunological function.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PsilocybinExperimental Treatment1 Intervention
Psilocybin (0.25mg/kg)
Group II: NiacinPlacebo Group1 Intervention
Niacin (250mg)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Obsessive-Compulsive Disorder (OCD) primarily involve the modulation of serotonin levels in the brain. Selective serotonin reuptake inhibitors (SSRIs) increase serotonin availability by inhibiting its reuptake, which helps alleviate OCD symptoms.
Clomipramine, a tricyclic antidepressant, also boosts serotonin and norepinephrine levels. Psilocybin, a serotonin 5-HT2A receptor agonist, is being studied for its unique way of modulating serotonin pathways, potentially offering new therapeutic benefits.
Understanding these mechanisms is crucial for OCD patients as it underscores the role of serotonin regulation in symptom management and highlights the potential for novel treatments that may be more effective or have fewer side effects.
Obsessive-compulsive disorder, impulse control disorders and drug addiction: common features and potential treatments.
Obsessive-compulsive disorder, impulse control disorders and drug addiction: common features and potential treatments.
Find a Location
Who is running the clinical trial?
National Institute of Mental Health (NIMH)NIH
2,820 Previous Clinical Trials
2,692,788 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,891 Patients Enrolled for Obsessive-Compulsive Disorder
Yale UniversityLead Sponsor
1,874 Previous Clinical Trials
2,953,525 Total Patients Enrolled
11 Trials studying Obsessive-Compulsive Disorder
566 Patients Enrolled for Obsessive-Compulsive Disorder
Heffter Research InstituteOTHER
13 Previous Clinical Trials
468 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a score of 18 or more on the YBOCS evaluation, which measures the severity of obsessive-compulsive disorder symptoms.I haven't taken SSRIs for at least 8 weeks.I am willing to stop taking psychiatric and certain other medications during the study.You have Obsessive-Compulsive Personality Disorder (OCPD) or Borderline Personality Disorder (BPD).I do not have uncontrolled diabetes, high blood pressure, heart issues, or a history of seizures or severe headaches.I will not start new psychiatric meds during the study without informing the team.The study participant must be willing to sign a medical release that allows the investigators to communicate directly with the study participant's therapist and doctors to confirm any medication and/or medical historyI must be medically approved to drive or have arranged a ride after my session.The participant must provide a contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of the participant becoming suicidal.You are currently feeling extremely sad or hopeless and have thoughts of wanting to harm yourself.You have autism.Your score on the Y-BOCS scale is 19 or higher, which indicates significant symptoms of obsessive-compulsive disorder.You have a problem with drugs or substances, except for mild alcohol use.You have used drugs that alter your perception and thinking, like psychedelics, in the past year.The DSM-5 diagnosis of OCD is established by a trained clinician interview and confirmed by Mini International Neuropsychiatric Interview MINI (edition 7).I have had a head injury where I was unconscious for over 30 minutes.I am willing to follow all study requirements, including staying in the hospital, undergoing tests, and reporting my health status.I have been diagnosed with OCD.I have someone who can be contacted by the study team in emergencies and can take me home after hospital stays.My Tourette syndrome has not improved.I have tried at least one standard OCD treatment without success.I stopped taking my SSRI medication long enough for it to be out of my system.You or someone in your close family has had schizophrenia, bipolar disorder, or severe depression with hallucinations.You cannot take any psychiatric medication while participating in the study.I have tried at least one standard OCD treatment without success.The person can understand what the study is, what is involved, the risks and benefits and they are able to consent to taking part in the study by giving written consent.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger