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| Name | Class |
|---|---|
| COMPASS Pathways | INDUSTRY |
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This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental | 25mg of Psilocybin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Open-Label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Modified Scale for Suicidal Ideation (MSSI) | The MSSI is an 18-item clinician rated scale to assess the presence or absence of suicide ideation and the degree of severity of suicidal ideas. Each of the 18 items is rated on a scale of 0 to 3 where a higher score indicates greater suicidal severity. | Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10) |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | The MADRS is a clinician rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. | Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Aaronson, MD | Sheppard Pratt Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42138588 | Derived | van der Vaart A, LaPratt J, Swartz K, Shoultz A, Lauterbach M, Suppes T, Sackeim HA, Aaronson ST. Efficacy and Safety of a Single Dose of Psilocybin for Chronic Suicidal Ideation: An Open-Label Trial. J Clin Psychiatry. 2026 May 13;87(2):26m16338. doi: 10.4088/JCP.26m16338. |
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| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D059020 | Suicidal Ideation |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| Concise Health Risk Tracking Self Report 12 Items (CHRT-SR) | The CHRT-SR is a 12-item self-report measure that systematically assesses both suicidal thinking and associated thoughts that might indicate the propensity for suicidal acts. | Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10) |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a semi-structured interview designed to assess the severity and intensity of suicidal ideation, suicidal behavior, and non-suicidal self injurious behavior over a specified time period. The measurement of suicidal ideation is based on five "yes" or "no" questions with accompanying descriptions arranged in order of increasing severity. | Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), and Week 12 (V10) |
| Clinical Global Impression - Modified for Depression (CGI-D) | The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response. | Baseline (V2) to Week 3 (V7) and Week 12 (V10) |
| Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI) | The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response. | Baseline (V2) to Week 3 (V7), and Week 12 (V10) |
| D016728 |
| Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |