Treatment Resistant Depression
Conditions
Brief summary
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
Detailed description
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
Interventions
DRUGPsilocybin
Dose-finding
Sponsors
COMPASS Pathways
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of TRD
Exclusion criteria
* Other comorbidities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 | Change from Baseline to Week 3 | MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score. |
| MADRS Change From Baseline to Week 3, Sensitivity Analysis | Change from Baseline to Week 3 | MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score. |
Countries
Canada, Czechia, Denmark, Germany, Ireland, Netherlands, Portugal, Spain, United Kingdom, United States
Participant flow
Recruitment details
First patient first visit: 1 March 2019 Last patients last visit: 27 September 2021
Participants by arm
| Arm | Count |
|---|---|
| 25 mg COMP360 Psilocybin 25 mg COMP360 Psilocybin | 79 |
| 10 mg COMP360 Psilocybin 10 mg COMP360 Psilocybin | 75 |
| 1 mg COMP360 Psilocybin 1 mg COMP360 Psilocybin | 79 |
| Total | 233 |
Baseline characteristics
| Characteristic | 10 mg COMP360 Psilocybin | 1 mg COMP360 Psilocybin | Total | 25 mg COMP360 Psilocybin |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 7 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 73 Participants | 77 Participants | 226 Participants | 76 Participants |
| Age, Continuous | 40.6 years STANDARD_DEVIATION 12.76 | 38.7 years STANDARD_DEVIATION 11.71 | 39.8 years STANDARD_DEVIATION 12.19 | 40.2 years STANDARD_DEVIATION 12.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 5 Participants | 12 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 72 Participants | 73 Participants | 215 Participants | 70 Participants |
| Region of Enrollment Canada | 2 participants | 2 participants | 6 participants | 2 participants |
| Region of Enrollment Czechia | 2 participants | 2 participants | 7 participants | 3 participants |
| Region of Enrollment Denmark | 2 participants | 3 participants | 8 participants | 3 participants |
| Region of Enrollment Germany | 2 participants | 0 participants | 4 participants | 2 participants |
| Region of Enrollment Ireland | 3 participants | 5 participants | 11 participants | 3 participants |
| Region of Enrollment Netherlands | 16 participants | 17 participants | 50 participants | 17 participants |
| Region of Enrollment Portugal | 0 participants | 1 participants | 2 participants | 1 participants |
| Region of Enrollment Spain | 6 participants | 5 participants | 16 participants | 5 participants |
| Region of Enrollment United Kingdom | 10 participants | 12 participants | 33 participants | 11 participants |
| Region of Enrollment United States | 32 participants | 32 participants | 96 participants | 32 participants |
| Sex: Female, Male Female | 34 Participants | 43 Participants | 112 Participants | 35 Participants |
| Sex: Female, Male Male | 41 Participants | 36 Participants | 121 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 75 | 0 / 79 |
| other Total, other adverse events | 60 / 79 | 51 / 75 | 50 / 79 |
| serious Total, serious adverse events | 5 / 79 | 6 / 75 | 1 / 79 |
Outcome results
Primary
MADRS Change From Baseline to Week 3, Sensitivity Analysis
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.
Time frame: Change from Baseline to Week 3
Population: The per-protocol analysis set includes all participants in the Full Analysis Set who do not have a protocol deviation that is thought to significantly affect the integrity of the participant's efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 mg COMP360 Psilocybin | MADRS Change From Baseline to Week 3, Sensitivity Analysis | -12 units on a scale | Standard Deviation 12.98 |
| 10 mg COMP360 Psilocybin | MADRS Change From Baseline to Week 3, Sensitivity Analysis | -8.9 units on a scale | Standard Deviation 11.11 |
| 1 mg COMP360 Psilocybin | MADRS Change From Baseline to Week 3, Sensitivity Analysis | -6.7 units on a scale | Standard Deviation 11.18 |
Comparison: Sensitivity analysis of the primary endpoint using the per-protocol analysis set.p-value: <0.0595% CI: [-9.4, -1.8]Mixed Models Analysis
Primary
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3
MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.
Time frame: Change from Baseline to Week 3
Population: The full analysis set includes all participants randomised who receive study drug and have at least 1 post-dose efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 mg COMP360 Psilocybin | Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 | -12 units on a scale | Standard Deviation 12.98 |
| 10 mg COMP360 Psilocybin | Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 | -8.9 units on a scale | Standard Deviation 10.94 |
| 1 mg COMP360 Psilocybin | Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3 | -6.8 units on a scale | Standard Deviation 11.1 |
Comparison: The primary analysis was the comparison between COMP360 (25 mg or 10 mg) versus COMP360 1 mg. The null hypothesis was that there was no difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg. The alternative hypothesis was that were was a difference in mean change from Baseline in MADRS total score at Week 3 for COMP360 25 mg or COMP360 10 mg versus COMP360 1 mg.p-value: <0.0595% CI: [-10.2, -2.9]Mixed Models Analysis