Pilot study of single-dose psilocybin for serotonin reuptake inhibitor-resistant body dysmorphic disorder.
Franklin R. Schneier, Jamie D. Feusner, Michael G. Wheaton, Gloria J. Gomez, Giselle Cornejo, Akansha Mahesh Naraindas, David J Hellerstein
Journal of Psychiatric Research May 1, 2023 DOI: 10.1016/j.jpsychires.2023.03.031 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label trial Randomized Pilot study Peer reviewed |
|---|---|
| Sample size | 12 |
| Population | Adults with moderate-to-severe non-delusional body dysmorphic disorder unresponsive to at least one serotonin reuptake inhibitor trial |
| Intervention | Psilocybin |
| Dose | 25 mg |
| Duration | 12 weeks of follow-up after a single dosing session |
| Topics | Psilocybin Serotonin |
| Keywords | Body dysmorphic disorder Clinical trial Psychedelic treatment Hallucinogenic medicine Dysmorphia Body image disorder Psychiatric studies |
| Citations | 79 |
| Key findings | A single 25 mg dose of psilocybin with psychological support led to significant and sustained reductions in BDD symptoms over 12 weeks, with 58% of participants classified as responders. |
Abstract
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. 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. 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. This study provides promising preliminary support for psilocybin as a treatment of BDD, warranting future controlled studies.
Comparable studies
Other non-randomized and open-label trials on serotonin, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Serotonin 2A Receptor Agonist Binding in the Human Brain with [11C]Cimbi-36 Healthy volunteers | 2014 | First-in-human clinical trial | n = 29 |
| Localization of serotonin 5‐HT2 receptors in living human brain by positron emission tomography using N1‐([11C]‐methyl)‐2‐BR‐LSD Normal human volunteers | 1987 | Clinical trial | n = 7 |
| Serotonin, Psilocybin, and Body Dysmorphic Disorder Adults with body dysmorphic disorder | 1996 | Open-label pilot study | n = 8 |
| Imprinting: expanding the extra-pharmacological model of psychedelic drug action to incorporate delayed influences of sets and settings Patients with treatment-resistant depression receiving serial intravenous ketamine... | 2023 | Retrospective review of clinical trial data with literature search | n = 26 |
| Effects of discontinuation of serotonergic antidepressants prior to psilocybin therapy versus escitalopram for major depression Patients with major depressive disorder | 2024 | Post hoc exploratory analysis of a clinical trial |
Citations in the library
Cited by 64
- Efficacy and safety of psychedelics for the treatment of mental disorders: A systematic review and meta-analysis. Psychiatry Research May 1, 2024
- Cardiovascular safety of psychedelic medicine: current status and future directions Pharmacological Reports October 24, 2023
- A Systematic Review of Reporting Practices in Psychedelic Clinical Trials: Psychological Support, Therapy, and Psychosocial Interventions. Psychedelic Medicine December 1, 2023
- Ethnoracial inclusion in clinical trials of psychedelics: a systematic review. EClinicalMedicine August 1, 2024
- Psychedelics in neuroinflammation: Mechanisms and therapeutic potential Progress in Neuro-Psychopharmacology and Biological Psychiatry January 31, 2025
and 59 more in the library
Cites 16
- Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry May 17, 2016
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology November 8, 2017
and 11 more in the library