Trial Outcomes & Findings for The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder (NCT NCT05312151)
NCT ID: NCT05312151
Last Updated: 2025-06-13
Results Overview
A TEAE is defined as an adverse event (AE) that has an onset on or after the dose of study drug, or any pre-existing AE condition that has worsened on or after the dose of study drug.
COMPLETED
PHASE2
22 participants
Up to 12 weeks
2025-06-13
Participant Flow
Participant milestones
| Measure |
COMP360 Psilocybin
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
COMP360 Psilocybin
n=22 Participants
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 7.91 • n=99 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
13 participants
n=99 Participants
|
|
CAPS-5 Total Symptom Severity Score
|
47.5 units on a scale
STANDARD_DEVIATION 9.78 • n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 12 weeksPopulation: Safety Analysis Set - all participants who received study drug.
A TEAE is defined as an adverse event (AE) that has an onset on or after the dose of study drug, or any pre-existing AE condition that has worsened on or after the dose of study drug.
Outcome measures
| Measure |
COMP360 Psilocybin
n=22 Participants
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set - all participant who received study drug.
CAPS-5 is a 30 item scale, each item is scored from 0-4, total severity score is calculated by taking the sum of the individual item scores (range: 0-80). Higher scores denote greater symptom severity.
Outcome measures
| Measure |
COMP360 Psilocybin
n=22 Participants
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline
|
-29.5 units on a scale
Standard Deviation 15.43
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set - all participants who received study drug.
CAPS-5 is a 30 item scale, each item is scored from 0-4, total severity score is calculated by taking the sum of the individual item scores (range: 0-80). Higher scores denote greater symptom severity. A participant is defined as a responder if they have a greater than or equal to 15 point improvement on the CAPS-5 total severity score compared to Baseline.
Outcome measures
| Measure |
COMP360 Psilocybin
n=22 Participants
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders
|
17 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set - All participants who received study drug.
CAPS-5 is a 30 item scale, each item is scored from 0-4, total severity score is calculated by taking the sum of the individual item scores (range: 0-80). Higher scores denote greater symptom severity. A participant is defined as remitter at any post-baseline timepoint if their CAPS-5 total severity score is less than or equal to 20.
Outcome measures
| Measure |
COMP360 Psilocybin
n=22 Participants
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Full Analysis Set - all participants who received study drug.
SDS is a 5 item scale. The total score is calculated by summing the 3 domains (work/school, social life, and family life - each domain has a 0-10 range). The total score has a range from 0 to 30, with 0 representing no impairment and 30 representing severe impairment.
Outcome measures
| Measure |
COMP360 Psilocybin
n=21 Participants
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Change in Sheehan Disability Scale (SDS) Total Score From Baseline
|
-14.4 units on a scale
Standard Deviation 8.21
|
Adverse Events
COMP360 Psilocybin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
COMP360 Psilocybin
n=22 participants at risk
25 mg COMP360 Psilocybin
Psilocybin: Open label
|
|---|---|
|
Eye disorders
Visual impairment
|
13.6%
3/22 • Number of events 3 • 12 Weeks
|
|
Gastrointestinal disorders
Nausea
|
36.4%
8/22 • Number of events 9 • 12 Weeks
|
|
General disorders
Crying
|
27.3%
6/22 • Number of events 6 • 12 Weeks
|
|
General disorders
Fatigue
|
27.3%
6/22 • Number of events 6 • 12 Weeks
|
|
General disorders
Chills
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Infections and infestations
COVID-19
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
13.6%
3/22 • Number of events 3 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Nervous system disorders
Tension headache
|
27.3%
6/22 • Number of events 9 • 12 Weeks
|
|
Nervous system disorders
Headache
|
27.3%
6/22 • Number of events 6 • 12 Weeks
|
|
Nervous system disorders
Paraesthesia
|
13.6%
3/22 • Number of events 3 • 12 Weeks
|
|
Nervous system disorders
Dizziness
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Psychiatric disorders
Hallucination, visual
|
22.7%
5/22 • Number of events 5 • 12 Weeks
|
|
Psychiatric disorders
Euphoric mood
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Psychiatric disorders
Paranoia
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
|
Psychiatric disorders
Suicidal ideation
|
9.1%
2/22 • Number of events 2 • 12 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place