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Trial Outcomes & Findings for Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder (NCT NCT04656301)

NCT ID: NCT04656301

Last Updated: 2023-03-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

From baseline (day -1) up to 3 months post-dose

Results posted on

2023-03-13

Participant Flow

Participant milestones

Participant milestones
Measure
Psilocybin
A single dose of Psilocybin 25mg p.o. Psilocybin: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Overall Study
STARTED
12
Overall Study
COMPLETED
12
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Psilocybin
n=12 Participants
A single dose of Psilocybin 25mg p.o. Psilocybin: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Age, Continuous
34.31 years
STANDARD_DEVIATION 8.86 • n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
Sex: Female, Male
Male
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
9 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
29.17 scale score
STANDARD_DEVIATION 4.60 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Psilocybin
n=12 Participants
A single dose of Psilocybin 25mg p.o. Psilocybin: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale
18.42 score on a scale
Standard Deviation 9.80

Adverse Events

Psilocybin

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Psilocybin
n=12 participants at risk
A single dose of Psilocybin 25mg p.o. Psilocybin: A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
General disorders
fatigue
41.7%
5/12 • Number of events 5 • 3 months
Nervous system disorders
headache
25.0%
3/12 • Number of events 3 • 3 months
Gastrointestinal disorders
nausea
16.7%
2/12 • Number of events 2 • 3 months
Nervous system disorders
somnolence
8.3%
1/12 • Number of events 1 • 3 months
Nervous system disorders
Lightheadedness
8.3%
1/12 • Number of events 1 • 3 months
Nervous system disorders
spaciness
8.3%
1/12 • Number of events 1 • 3 months
General disorders
insomnia
8.3%
1/12 • Number of events 1 • 3 months
Infections and infestations
COVID-19
8.3%
1/12 • Number of events 1 • 3 months
Infections and infestations
pneumonia
8.3%
1/12 • Number of events 1 • 3 months
Reproductive system and breast disorders
low libido
8.3%
1/12 • Number of events 1 • 3 months
Psychiatric disorders
emotional lability
8.3%
1/12 • Number of events 1 • 3 months
Psychiatric disorders
visual hallucination
8.3%
1/12 • Number of events 4 • 3 months

Additional Information

Dr. Franklin Schneier

NY State Psychiatric Institute

Phone: 6467748041

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60