Adults 18 to 55, any sex, with Body Dysmorphic Disorders. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder ScalePrimary· From baseline (day -1) up to 3 months post-dose
The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item, semi-structured, rater-administered measure that assesses body dysmorphic disorder severity during the past week. Scores for each item range from 0 (no symptoms) to 4 (extreme symptoms); the total score ranges from 0 to 48, with higher scores reflecting more severe symptoms.
Group
Value
95% CI
Psilocybin
18.42
± 9.80
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
In this pilot study 12 adult outpatients with body dysmorphic disorder that has not responded to at least one adequate trial of a serotonin reuptake inhibitor will be treated openly with a single oral dose of psilocybin. Followup visits to monitor safety and clinical outcome will be conducted over a 3 month period.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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 Body Dysmorphic Disorders
Currently open trials in the same condition.
NCT06262412 — Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder
· NA
· recruiting
NCT03918577 — Caloric Vestibular Stimulation for Modulation of Insight in Obsessive-Compulsive Spectrum Disorders
· NA
· recruiting
NCT04899687 — Study of Dextromethorphan in OCD and Related Disorders
· Phase 2
· recruiting
Other New York State Psychiatric Institute trials
Trials by the same sponsor.
NCT05416658 — Shared Decision Making for Antipsychotic Medications
· NA
· not yet recruiting
NCT07423546 — A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia
· Phase 1, PHASE2
· not yet recruiting
NCT05339256 — Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual
· Phase 2
· not yet recruiting
NCT05563948 — Repeated Administration of Cannabis Varying in THC and CBD
· Phase 2
· suspended
NCT06977308 — A Multimodal Imaging Study of Dopamine in Early Psychosis
· Phase 1
· not yet recruiting
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 New York State Psychiatric Institute
Last refreshed: 13 March 2023
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/NCT04656301.