Treatment Resistant Depression
Conditions
Brief summary
The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression
Detailed description
A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.
Interventions
DRUGPsilocybin
Open label
Sponsors
COMPASS Pathways
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed ICF. 2. 18 years of age or older 3. At least moderate MDD 4. Hamilton Depression Rating Scale (17 item) score ≥18 5. Currently receiving treatment with a selective serotonin reuptake inhibitor 6. Failure to respond to an adequate dose and duration of 2, 3, or 4 pharmacological treatments 7. McLean Screening Instrument for Borderline Personality Disorder \<7 at Screening (V1). 8. Ability to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.
Exclusion criteria
Psychiatric
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Depressive Symptoms | 3 weeks | Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Response | 3 weeks | The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from Baseline) at Week 3 post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome. |
| Incidence of Remission | 3 weeks | The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale \[MADRS\] total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome. |
| Improvement in Clinical Global Impression - Severity | 3 weeks | Changes from Baseline in Clinical Global Impression-Severity score at Week 3 post psilocybin administration. The minimum and maximum values are 1 and 7 and a higher score means a worse outcome. |
Countries
Ireland, United States
Participant flow
Recruitment details
First patient first visit: 10 August 2020 Last patient last visit: 13 October 2021
Participants by arm
| Arm | Count |
|---|---|
| Psilocybin 25mg Psilocybin
Psilocybin: Open label | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Psilocybin |
|---|---|
| Age, Categorical <=18 years | 4 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 42.2 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 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 | 2 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment Ireland | 10 participants |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 12 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Improvement in Depressive Symptoms
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to 3 weeks post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Time frame: 3 weeks
Population: Full analysis set - all participants who receive study drug and have at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 mg COMP360 Psilocybin | Improvement in Depressive Symptoms | -14.9 units on a scale | Standard Deviation 11.97 |
Secondary
Improvement in Clinical Global Impression - Severity
Changes from Baseline in Clinical Global Impression-Severity score at Week 3 post psilocybin administration. The minimum and maximum values are 1 and 7 and a higher score means a worse outcome.
Time frame: 3 weeks
Population: Full analysis set - All participants who receive study drug and have at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 25 mg COMP360 Psilocybin | Improvement in Clinical Global Impression - Severity | -1.3 units on a scale | Standard Deviation 1.29 |
Secondary
Incidence of Remission
The proportion of participants with remission (defined as Montgomery-Asberg Depression Rating Scale \[MADRS\] total score ≤ 10) at Week 3 post psilocybin administration The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Time frame: 3 weeks
Population: Full analysis set - All participants who receive study drug and have at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mg COMP360 Psilocybin | Incidence of Remission | 8 Participants |
Secondary
Incidence of Response
The proportion of participants with a response (defined as a ≥ 50% improvement in Montgomery-Asberg Depression Rating Scale \[MADRS\] total score from Baseline) at Week 3 post psilocybin administration. The minimum and maximum MADRS total score values are 0 and 60 and a higher score means a worse outcome.
Time frame: 3 weeks
Population: Full analysis set - all participants who receive study drug and have at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 25 mg COMP360 Psilocybin | Incidence of Response | 8 Participants |