Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05546658
Status:
RECRUITING
Last Update Posted:
2025-11-07
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Psilocybin in Obsessive Compulsive Disorder
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Effects of Psilocybin in Obsessive Compulsive Disorder
Status:
RECRUITING
Status Verified Date:
2025-11
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 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.
Detailed Description:
Participants in this study will receive two doses of psilocybin approximately two weeks apart. Assessments will be conducted during screening visits, psilocybin sessions, and at follow up visits up to 6 months after the final psilocybin session. Thirty participants will complete all study visits including follow-up visits.
Primary objectives:
1. Investigate the feasibility, safety, and acceptability of psilocybin for OCD.
2. Investigate the effect of psilocybin on OCD symptoms and concomitant depression and anxiety symptoms.
3. Investigate the effect of psilocybin on quality of life.
Secondary objectives:
1. Investigate the effect of psilocybin on metacognition of episodic memory and decision-making.
2. Investigate the effect of psilocybin on model-based learning.
3. Investigate the effect of psilocybin on the ERN.
4. Investigate the effect of psilocybin on affect and social connection.
5. Investigate the effect of psilocybin on movement and communications.
Primary objectives:
1. Investigate the feasibility, safety, and acceptability of psilocybin for OCD.
2. Investigate the effect of psilocybin on OCD symptoms and concomitant depression and anxiety symptoms.
3. Investigate the effect of psilocybin on quality of life.
Secondary objectives:
1. Investigate the effect of psilocybin on metacognition of episodic memory and decision-making.
2. Investigate the effect of psilocybin on model-based learning.
3. Investigate the effect of psilocybin on the ERN.
4. Investigate the effect of psilocybin on affect and social connection.
5. Investigate the effect of psilocybin on movement and communications.
Study Oversight
Has Oversight DMC:
True
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?: