Post Traumatic Stress DisorderPhase 2NCT05312151
The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
A Phase 2 study testing Psilocybin in people with Post Traumatic Stress Disorder, run by COMPASS Pathways at 3 sites in 2 countries.
Trial summary
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Jun 2022to 12 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood measured via the PCL-5 in combination with the LEC-5 at screening
- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood as assessed by the CAPS, with a minimum score of 25 at baseline
- Able to identify a next of kin who is willing and able to be reached by the investigators in case of emergency
- Have successfully discontinued all prohibited medications at least two weeks prior to baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of run-in will be required prior to baseline
Who cannot join
- Current or past history of schizophrenia, schizoaffective disorder or any other form of psychotic disorder, obsessive compulsive disorder, personality disorders, bipolar disorder, or any other significant disorder as assessed by clinician judgement and a structured clinical interview (MINI 7.0.2)
- Diagnosis of complex PTSD according to clinician judgement
- Borderline Personality Disorder as demonstrated by both the McLean Screening Instrument for Borderline Personality Disorder (MSI- BPD) score ≥ 7 and clinical confirmation of diagnosis by the study clinician and Medical Monitor
- Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during screening or at baseline, or; (2) suicidal behaviours within the past year, or; (3) history of serious suicide attempt that required a rescuing medical intervention, or; (4) clinical assessment of significant suicidal risk during participant interview
- Current (within the last year) alcohol or substance use disorder as informed by DSM-5 assessed via the MINI 7.0.2 at screening
- Other personal circumstances and behaviour judged to be incompatible with establishment of rapport or safe exposure to psilocybin
Show all 11Show fewer
- Exposure to 3,4-methylenedioxymethamphetamine (MDMA), psilocybin, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), or peyote in the past year
- Primary diagnosis of major depressive disorder within 6 months of study entry
- Exposure to a traumatic experience in the past 3 months
- Significant childhood physical or sexual abuse based on clinician judgment with the use of CTQ
- Enrolment in a psychological therapy programme that will not remain stable for the duration of the study. Psychological therapies cannot have been initiated within 21 days of baseline
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Sunstone Therapies
Rockville, Maryland, 20850
United Kingdom1 site
Kings College London, Institute of Psychiatry, Psychology and Neurology
London
About this study
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
Read the detailed description
The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Psilocybin
- Keywords
- psilocybin, COMP360, COMPASS, PTSD, Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called COMP360
Open label
| Study group | Role | What they receive |
|---|---|---|
| COMP360 Psilocybin | Experimental | 25 mg COMP360 Psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
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.
Measured: Up to 12 weeks
Secondary outcomes (4)
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline
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.
Measured: Week 12
Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders
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.
Measured: Week 12
Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.
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.
Measured: Week 12
Change in Sheehan Disability Scale (SDS) Total Score From Baseline
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 Jun 2022
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- COMPASS Pathways
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312151
- Sponsor's protocol ID
- COMP 201
- Status last verified
- May 2025
- First submitted
- 28 Mar 2022
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Dougherty RF, Modlin NL, McGowan NM, Staples P, Williams E, Clarke P, Shafiei M, Leininger C, Alti M, Croal M, Marwood L, Kirlic N, Ryslik GA, Goodwin GM. Silence is golden: Documenting the speech production of participants and support providers in psilocybin administration sessions for the treatment of post-traumatic stress disorder. J Psychopharmacol. 2026 Jul 16:2698811261464988. doi: 10.1177/02698811261464988. Online ahead of print.
PubMed 42460632Modlin NL, Williamson V, Goodwin GM, Malievskaia E, Atli M, Elek Z, Gaillard A, Koelpin D, Cleare A, Agrawal M, Yehuda R, Kirlic N, Rucker J. Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment. EClinicalMedicine. 2025 Dec 5;90:103692. doi: 10.1016/j.eclinm.2025.103692. eCollection 2025 Dec.
PubMed 41497513McGowan NM, Rucker JJ, Yehuda R, Agrawal M, Modlin NL, Simmons H, Tofil-Kaluza A, Das S, Goodwin GM. Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial. J Psychopharmacol. 2026 Jan;40(1):139-148. doi: 10.1177/02698811251362390. Epub 2025 Aug 29.
PubMed 40883964
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT05312151
- Acronym / sponsor ID
- COMP 201
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- psilocybin, COMP360, COMPASS, PTSD, Post Traumatic Stress Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- COMPASS PathwaysIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Safety and Tolerability of COMP360 in Participants with Post-traumatic Stress Disorder
Detailed description
The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMP360 Psilocybin | Experimental | Drug: Psilocybin25 mg COMP360 Psilocybin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood measured via the PCL-5 in combination with the LEC-5 at screening
- Meet DSM-5 criteria for current PTSD resulting from a trauma experienced during adulthood as assessed by the CAPS, with a minimum score of 25 at baseline
- Able to identify a next of kin who is willing and able to be reached by the investigators in case of emergency
- Have successfully discontinued all prohibited medications at least two weeks prior to baseline visit. For fluoxetine (Prozac), immediate cessation at screening period visit 1a followed by at least four weeks of run-in will be required prior to baseline
Key exclusion criteria (11 listed)
- Current or past history of schizophrenia, schizoaffective disorder or any other form of psychotic disorder, obsessive compulsive disorder, personality disorders, bipolar disorder, or any other significant disorder as assessed by clinician judgement and a structured clinical interview (MINI 7.0.2)
- Diagnosis of complex PTSD according to clinician judgement
- Borderline Personality Disorder as demonstrated by both the McLean Screening Instrument for Borderline Personality Disorder (MSI- BPD) score ≥ 7 and clinical confirmation of diagnosis by the study clinician and Medical Monitor
- Significant suicide risk as defined by (1) suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within the past year, during screening or at baseline, or; (2) suicidal behaviours within the past year, or; (3) history of serious suicide attempt that required a rescuing medical intervention, or; (4) clinical assessment of significant suicidal risk during participant interview
- Current (within the last year) alcohol or substance use disorder as informed by DSM-5 assessed via the MINI 7.0.2 at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinAlso: COMP360Open label | Drug | COMP360 Psilocybin |
Primary outcome
Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: 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.
4 secondary outcomes
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score From Baseline
Time frame: Week 12
Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders
Time frame: Week 12
Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters.
Time frame: Week 12
Change in Sheehan Disability Scale (SDS) Total Score From Baseline
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42460632Dougherty RF, Modlin NL, McGowan NM, Staples P, Williams E, Clarke P, Shafiei M, Leininger C, Alti M, Croal M, Marwood L, Kirlic N, Ryslik GA, Goodwin GM. Silence is golden: Documenting the speech production of participants and support providers in psilocybin administration sessions for the treatment of post-traumatic stress disorder. J Psychopharmacol. 2026 Jul 16:2698811261464988. doi: 10.1177/02698811261464988. Online ahead of print.
- Derived from this study: PubMed 41497513Modlin NL, Williamson V, Goodwin GM, Malievskaia E, Atli M, Elek Z, Gaillard A, Koelpin D, Cleare A, Agrawal M, Yehuda R, Kirlic N, Rucker J. Investigational psilocybin treatment for post-traumatic stress disorder: a qualitative study of participant experience, trauma engagement, and differences from standard treatment. EClinicalMedicine. 2025 Dec 5;90:103692. doi: 10.1016/j.eclinm.2025.103692. eCollection 2025 Dec.
- Derived from this study: PubMed 40883964McGowan NM, Rucker JJ, Yehuda R, Agrawal M, Modlin NL, Simmons H, Tofil-Kaluza A, Das S, Goodwin GM. Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial. J Psychopharmacol. 2026 Jan;40(1):139-148. doi: 10.1177/02698811251362390. Epub 2025 Aug 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Post Traumatic Stress Disorder, run by COMPASS Pathways at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05312151, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.