Trial · NCT05312151

The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

NCT05312151, Phase 2, Completed, COMPASS Pathways; results first posted 2025-06-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder. Trials, record NCT05312151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05312151

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
NCT number: NCT05312151
Status: Completed
Phases: Phase 2
Enrollment: 22 participants, actual
Lead sponsor: COMPASS Pathways
Conditions: Post Traumatic Stress Disorder
Interventions: Psilocybin
First posted: 2022-04-05
Last updated: 2025-06-13
Results first posted: 2025-06-13

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Up to 12 weeks	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.
Secondary	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline	Week 12	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.
Secondary	Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders	Week 12	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.
Secondary	Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.	Week 12	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.
Secondary	Change in Sheehan Disability Scale (SDS) Total Score From Baseline	Week 12	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	Up to 12 weeks	Safety Analysis Set - all participants who received study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline	Week 12	Full Analysis Set - all participant who received study drug.	units on a scale	MEAN
SECONDARY	Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders	Week 12	Full Analysis Set - all participants who received study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.	Week 12	Full Analysis Set - All participants who received study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Sheehan Disability Scale (SDS) Total Score From Baseline	Week 12	Full Analysis Set - all participants who received study drug.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	COMP360 Psilocybin	22		Participants
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline	COMP360 Psilocybin	-29.5	Standard Deviation 15.43	units on a scale
Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders	COMP360 Psilocybin	17		Participants
Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.	COMP360 Psilocybin	12		Participants
Change in Sheehan Disability Scale (SDS) Total Score From Baseline	COMP360 Psilocybin	-14.4	Standard Deviation 8.21	units on a scale

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	COMP360 Psilocybin	22
Overall Study	COMPLETED	COMP360 Psilocybin	22
Overall Study	NOT COMPLETED	COMP360 Psilocybin	0

Source ClinicalTrials.gov

Adverse events17

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Visual impairment	Eye disorders	COMP360 Psilocybin	3	22	3
other	Nausea	Gastrointestinal disorders	COMP360 Psilocybin	8	22	9
other	Crying	General disorders	COMP360 Psilocybin	6	22	6
other	Fatigue	General disorders	COMP360 Psilocybin	6	22	6
other	Chills	General disorders	COMP360 Psilocybin	2	22	2
other	COVID-19	Infections and infestations	COMP360 Psilocybin	2	22	2
other	Muscle tightness	Musculoskeletal and connective tissue disorders	COMP360 Psilocybin	3	22	3
other	Back pain	Musculoskeletal and connective tissue disorders	COMP360 Psilocybin	2	22	2
other	Myalgia	Musculoskeletal and connective tissue disorders	COMP360 Psilocybin	2	22	2
other	Tension headache	Nervous system disorders	COMP360 Psilocybin	6	22	9

1 to 10 of 17Source ClinicalTrials.gov

See all 17 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	COMP360 Psilocybin	0	22
Total, other adverse events	COMP360 Psilocybin	22	22
Total, serious adverse events	COMP360 Psilocybin	0	22

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
40883964	DERIVED	PubMed
41497513	DERIVED	PubMed
42460632	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05312151

GET https://conductscience.org/api/trials/v1/NCT05312151/registered

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