NCT05546658 is a EARLY_PHASE1 clinical trial of Psilocybin in Obsessive-Compulsive Disorder, sponsored by Johns Hopkins University.

Who is sponsoring NCT05546658?

NCT05546658 is sponsored by Johns Hopkins University.

What drugs are being tested in NCT05546658?

Interventions in NCT05546658: Psilocybin.

What condition does NCT05546658 study?

NCT05546658 studies Obsessive-Compulsive Disorder.

Is NCT05546658 still recruiting?

NCT05546658 is currently active, enrolled. Last updated 2 April 2026.

Last reviewed 2026-04-02 · How we verify

NCT05546658

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects of Psilocybin in Obsessive Compulsive Disorder

Active, enrolled EARLY_PHASE1 Last updated 2 April 2026

What this trial tests

EARLY_PHASE1 trial testing Psilocybin in Obsessive-Compulsive Disorder in 35 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 November 2022

Primary endpoint
12 September 2026

12 September 2027

Quick facts

Lead sponsor	Johns Hopkins University
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	28 November 2022
Primary completion	12 September 2026
Estimated completion	12 September 2027
Sites	1 location across United States

Drugs / interventions tested

Psilocybin — full drug profile →

Conditions studied

Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →

Sponsor

Johns Hopkins University

Who can join

Adults 21 to 80, any sex, with Obsessive-Compulsive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7
Psychedelics for the Treatment of Obsessive-Compulsive Disorder: Efficacy and Proposed Mechanisms.
Collins HM. · · 2024 · cited 8× · PMID 39611453 · DOI 10.1093/ijnp/pyae057
Hereditary Patterns and Genetic Associations in Obsessive-Compulsive Disorder (OCD): Neuropsychiatric Insights, Genetic Influences, and Treatment Perspectives.
Dhiman A, Mehan S, Khan Z, Tiwari A, et al · · 2025 · cited 4× · PMID 39219434 · DOI 10.2174/0115665232316708240828063527
Artificial Intelligence in Obsessive-Compulsive Disorder: A Systematic Review.
Kim J, Pacheco JPG, Golden A, Aboujaoude E, et al · · 2025 · cited 2× · PMID 40524733 · DOI 10.1007/s40501-025-00359-8
Psilocybin in pharmacotherapy of obsessive-compulsive disorder.
Owe-Larsson M, Kamińska K, Buchalska B, Mirowska-Guzel D, et al · · 2024 · cited 1× · PMID 39088105 · DOI 10.1007/s43440-024-00633-1

Verify or expand the search:

Other trials of Psilocybin

Trials testing the same drug.

NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting
NCT07226232 — Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression · Phase 3 · not yet recruiting
NCT07336238 — Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or · Phase 2 · recruiting
NCT07506395 — Group Psilocybin-Assisted Therapy for Post-Traumatic Stress Disorder · Phase 1 · not yet recruiting

Other recruiting trials for Obsessive-Compulsive Disorder

Currently open trials in the same condition.

NCT06575075 — Pilot Study of RR-HNK in OCD · Phase 1, PHASE2 · recruiting
NCT05783817 — MDMA-Assisted CBT for OCD (MDMA-CBT4OCD Study) · Phase 2 · recruiting
NCT07065669 — Treating Adolescent Obsessive Compulsive Disorder With Transcranial Magnetic Stimulation · NA · recruiting
NCT06376734 — Search for Novel Transcranial Magnetic Stimulation (TMS) Targets for Mental Illness · Phase 2 · recruiting
NCT07000812 — EEG Evaluation of CBT for Obsessive-Compulsive Disorder · NA · active not recruiting

Other Johns Hopkins University trials

Trials by the same sponsor.

NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05546658 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
Last refreshed: 2 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05546658.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing