Post Traumatic Stress Disorder
Conditions
Keywords
psilocybin, COMP360, COMPASS, PTSD, Post Traumatic Stress Disorder
Brief summary
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
Interventions
DRUGPsilocybin
Open label
Sponsors
COMPASS Pathways
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| COMP360 Psilocybin 25 mg COMP360 Psilocybin
Psilocybin: Open label | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | COMP360 Psilocybin |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Age, Continuous | 39.0 years STANDARD_DEVIATION 7.91 |
| CAPS-5 Total Symptom Severity Score | 47.5 units on a scale STANDARD_DEVIATION 9.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United Kingdom | 13 participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 22 |
| other Total, other adverse events | 22 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
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.
Time frame: Up to 12 weeks
Population: Safety Analysis Set - all participants who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COMP360 Psilocybin | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 22 Participants |
Secondary
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.
Time frame: Week 12
Population: Full Analysis Set - all participant who received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COMP360 Psilocybin | 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
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.
Time frame: Week 12
Population: Full Analysis Set - all participants who received study drug.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| COMP360 Psilocybin | Change in Sheehan Disability Scale (SDS) Total Score From Baseline | -14.4 units on a scale | Standard Deviation 8.21 |
Secondary
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.
Time frame: Week 12
Population: Full Analysis Set - all participants who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COMP360 Psilocybin | Proportion of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Responders | 17 Participants |
Secondary
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.
Time frame: Week 12
Population: Full Analysis Set - All participants who received study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| COMP360 Psilocybin | Proportion of Clinician-Administered PTSD Scale From DSM-5 (CAPS-5) Remitters. | 12 Participants |