Trial PaperDepressive DisordersAnxiety DisordersObsessive-Compulsive Disorder (OCD)SuicidalitySafety & Risk ManagementPsilocybin

Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder

This open-label study (n=12) of patients suffering from Body dysmorphic disorder (BDD), an obsessive preoccupation with misperceptions of appearance, finds that psilocybin (25mg) plus psychological support (6 sessions) resulted in a response (>30% decrease in BDD-YBOCS) in 58% of participants. Secondary measures such as negative affect, disability, and conviction of belief also significantly decreased.

Authors

  • David Hellerstein

Published

Journal of Psychiatric Research
individual Study

Abstract

Objective

Body dysmorphic disorder (BDD) is an often-severe condition in which individuals are preoccupied by misperceptions of their appearance as defective or ugly. Only serotonin reuptake inhibitors and cognitive-behavioral therapy have been demonstrated efficacious in randomized controlled trials. Psilocybin is a psychedelic drug with growing evidence for safety and efficacy in treatment of depression. This study aimed to pilot test the feasibility, tolerability, safety, and efficacy of psilocybin treatment of adults with BDD.

Methods

In this open-label trial, 12 adults (8 women, 4 men) with moderate-to-severe non-delusional BDD that had been unresponsive to at least one serotonin reuptake inhibitor trial received a single oral dose of psilocybin 25 mg. There was no control group. Psychological support was provided before, during, and after the dosing session. The primary outcome measure for efficacy was the Yale-Brown Obsessive Compulsive Disorder Scale Modified for BDD (BDD-YBOCS) score during 12 weeks of assessments after dosing.

Results

All participants completed dosing and all follow-up assessments. BDD-YBOCS scores decreased significantly over 12 weeks of follow-up (p < .001) with a large effect size (partial eta squared = 0.54), and significant changes from baseline were present at week 1 and persisted through week 12. Secondary efficacy measures of BDD symptoms, conviction of belief, negative affect, and disability also improved significantly, and no serious adverse events occurred. At week 12, seven participants (58%) were rated responders, based on ≥30% decrease in BDD-YBOCS.

Conclusion

This study provides promising preliminary support for psilocybin as a treatment of BDD, warranting future controlled studies.

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Research Summary of 'Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder'

Introduction

Body dysmorphic disorder (BDD) is characterised by preoccupation with perceived defects in appearance, and is associated with obsessive thoughts, compulsive behaviours, anxiety, social withdrawal, depression and a high rate of suicide attempts. Schneier and colleagues note that only selective serotonin reuptake inhibitors (or clomipramine) and disorder-specific cognitive behavioural therapy have demonstrated efficacy in randomised controlled trials, leaving a substantial unmet need for novel treatments. Psilocybin, a 5-HT2A/5-HT1A partial agonist, has shown growing evidence of efficacy in mood disorders and preliminary findings in obsessive–compulsive and substance-use disorders; mechanistically, it may reduce rigid thinking and alter bodily self-awareness, features relevant to BDD. A single case report also suggested possible benefit in BDD after unsupervised psilocybin use, motivating further investigation. This study aimed to pilot the feasibility, tolerability, safety and preliminary efficacy of a single 25 mg oral dose of psilocybin given with manualised psychological support in adults with non‑delusional BDD who had previously failed at least one serotonin reuptake inhibitor (SRI) trial. The investigators designed an open‑label proof‑of‑concept trial with 12 weeks of follow‑up to assess symptom change on the BDD‑YBOCS and a range of secondary clinical and safety measures, to determine whether controlled studies are warranted.

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Study Details

References (11)

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