Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-02 @ 12:26 AM
Study NCT ID:
NCT04052568
Status:
COMPLETED
Last Update Posted:
2023-05-06
First Post:
2019-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Psilocybin in Anorexia Nervosa
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Effects of Psilocybin in Anorexia Nervosa
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to decrease depression and anxiety and increase long-term positive behavior change in other populations. The investigators seek to determine whether similar changes can be safely produced in people with AN when psilocybin is administered in a supportive setting with close follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in people with AN, that it will reduce measures of anxiety and depression, and that it will lead to increased quality of life. The investigators will also assess a number of exploratory measures related to eating disorder pathophysiology.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: