What side effects are associated with this type of intervention?

Common treatments for Obsessive-Compulsive Disorder (OCD) include Selective Serotonin Reuptake Inhibitors (SSRIs) and Clomipramine. SSRIs can cause side effects such as nausea, headache, sexual dysfunction, insomnia, and weight gain. Clomipramine may lead to dry mouth, constipation, urinary retention, and dizziness. Psilocybin, a serotonin 5-HT2A receptor agonist being studied for OCD, has been reported to cause transient anxiety, nausea, and perceptual changes during its acute effects, which are generally short-lived and resolve without long-term consequences.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Obsessive-Compulsive Disorder (OCD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, fluvoxamine, sertraline, paroxetine, and escitalopram. Clomipramine, a tricyclic antidepressant, is also approved for OCD. These medications work by increasing serotonin levels in the brain, which helps alleviate OCD symptoms. Psilocybin, a Serotonin 5-HT2A Receptor Agonist currently being studied, shares a similar mechanism of action by targeting serotonin receptors, although it is not yet FDA-approved for OCD.

What other types of research exist?

Promising novel alternatives to Psilocybin for OCD treatment include Deep Brain Stimulation (DBS), which involves the implantation of electrodes to modulate brain activity, and Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain. Both have shown potential in preliminary studies for treatment-refractory OCD.

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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

Summary

This trial tests psilocybin from 'magic mushrooms' on patients with OCD who don't respond well to usual treatments. It aims to see if psilocybin can improve symptoms by helping 'reset' brain connections. Psilocybin has shown promising results in treating various psychiatric disorders, including depression, anxiety, and substance use disorders.

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.

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.

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 below

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I haven't taken SSRIs for at least 8 weeks.

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I have been diagnosed with OCD.

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I stopped taking my SSRI medication long enough for it to be out of my system.

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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:

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I do not have uncontrolled diabetes, high blood pressure, heart issues, or a history of seizures or severe headaches.

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I have had a head injury where I was unconscious for over 30 minutes.

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My Tourette syndrome has not improved.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 days post-drug, weeks: 1, 2, 4, 12 post-drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 days post-drug, weeks: 1, 2, 4, 12 post-drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 days post-drug, weeks: 1, 2, 4, 12 post-drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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 more

Other study objectives

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Psilocybin (0.25mg/kg)

2018

Completed Phase 1

~40

0 / 7Eligibility criteria met

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.