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

Sponsor

COMPASS Pathways (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05312151

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Drug: Psilocybin	Phase 2

Detailed Description

The Safety and Tolerability of COMP360 administered under supportive conditions in participants with Post-traumatic Stress Disorder

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COMP360 Psilocybin 25 mg COMP360 Psilocybin	Drug: Psilocybin Open label Other Names: COMP360

Arm

Intervention/Treatment

Experimental: COMP360 Psilocybin

25 mg COMP360 Psilocybin

Drug: Psilocybin

Open label

Other Names:

COMP360

Outcome Measures

Primary Outcome Measures

Safety [Up to 12 weeks]
Proportion of patients with adverse events (AEs)

Secondary Outcome Measures

Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline [Up to 12 weeks]
CAPS-5 is a 30 item scale, each item is scored from 0-4; Higher scores denote greater severity for each item
Change in PTSD checklist for DSM-5 (PCL-5) from baseline [Up to 12 weeks]
PCL-5 is a 20-item self-reported scale, each item is scored from 0-4; Higher scores denote greater severity for each item
Change in Sheehan Disability Scale (SDS) total score from baseline [Up to 12 weeks]
SDS is a 5-item scale, the total score is from 0 to 30; Higher scores denote greater impairment of function

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

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:

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 the International Trauma Questionnaire (ITQ)
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
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029
2	Kings College London, Institute of Psychiatry, Psychology and Neurology	London		United Kingdom