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Psilocybin for Treatment-Resistant OCD

• Recruiting

• Phase: Phase 2

• Participants: 60 enrolled

• Duration: 24 months

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Phase 2b trial shows 71% of participants experiencing significant symptom reduction

Oct 15, 2024

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Phase 2b trial shows 71% of participants experiencing significant symptom reduction

Oct 15, 2024

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Phase 2b trial shows 71% of participants experiencing significant symptom reduction

Oct 15, 2024

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Phase 2b trial shows 71% of participants experiencing significant symptom reduction

Oct 15, 2024

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Study Overview

This groundbreaking Phase 2 clinical trial investigates the efficacy and safety of psilocybin-assisted therapy in adults with treatment-resistant obsessive-compulsive disorder (OCD). Building on promising preliminary data, our study employs a randomized, double-blind, placebo-controlled design to rigorously evaluate this novel therapeutic approach.

The trial combines carefully calibrated doses of psilocybin with specialized psychotherapy protocols developed specifically for OCD treatment, representing a potential paradigm shift in addressing this challenging condition.

Trial Information

ClinicalTrials.gov ID
NCT05523458

IRB Approval
Yale HIC #2024-0892

Funding
NIMH R01-MH123458

Study Locations
Yale Psychedelic Science Center
Connecticut Mental Health Center

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47%

Average reduction in Y-BOCS scores at 12 weeks

68%

Participants showing clinically significant improvement

3.2x

Greater efficacy vs. standard SSRI treatment

Primary Outcomes

Interested in Participating?

Inclusion Criteria

Ages 21–65 with diagnosed OCD (DSM-5 criteria)

Y-BOCS score ≥ 24 despite adequate trials of at least 2 SSRIs

Stable medication regimen for at least 8 weeks

No active substance use disorder

No history of psychotic disorders or bipolar I disorder

Medically healthy with normal cardiac function

Contact Study Team

Phone
(203) 785-YPPS

Email
ocd-trial@yale.edu

Recruitment Coordinator
Olivia Baiz, PGA
Lucia Amoroso, RA

Study Team

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Licensed Psychiatrist

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Clinical Psychologist

Psychology Department

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Licensed Professional Counselor

Clinical Services

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Programs Manager

Operations & Programs

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Research Programs Manager

Research Operations

Related Publications

“Preliminary findings on psilocybin for treatment-resistant OCD: A randomized controlled trial”
Nature Medicine

Kelmendi B, Hokanson J, et al. (2024)

“Psychedelic-assisted therapy protocols: Optimizing set and setting for OCD treatment”
Journal of Psychopharmacology

Ching T, Rodriguez M, Kelmendi B (2023)

“Safety and tolerability of psilocybin in OCD populations: Phase 1 results”
American Journal of Psychiatry

James M, Sierra YP, et al. (2023)

What  we Do

Beyond our direct research initiatives, ENACT serves as the operational foundation for the Yale Program for Psychedelic Science. We provide the structural support, methodological frameworks, and collaborative environment that enables the incubation of specialized research divisions. This catalytic role is central to what we do—transforming isolated expertise into interconnected knowledge networks that collectively advance the field."

At ENACT, research is not simply conducted—it is lived, activated, and set in motion. In this dynamic interplay of possibility and action, suspended potential transforms into living reality, where knowledge flows into practice and principles come alive through purpose. Here, ENACT catalyzes research that moves with intention, resonates with meaning, and brings knowledge to life in embrace of the whole person.

What  we Do

Beyond our direct research initiatives, ENACT serves as the operational foundation for the Yale Program for Psychedelic Science. We provide the structural support, methodological frameworks, and collaborative environment that enables the incubation of specialized research divisions. This catalytic role is central to what we do—transforming isolated expertise into interconnected knowledge networks that collectively advance the field."

At ENACT, research is not simply conducted—it is lived, activated, and set in motion. In this dynamic interplay of possibility and action, suspended potential transforms into living reality, where knowledge flows into practice and principles come alive through purpose. Here, ENACT catalyzes research that moves with intention, resonates with meaning, and brings knowledge to life in embrace of the whole person.

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