Suicidal Ideation, Treatment Resistant Depression
Conditions
Keywords
Psilocybin, Psychedelic, Major depression, Treatment resistant depression, Suicidal ideation
Brief summary
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
Interventions
DRUGPsilocybin
Open-Label
Sponsors
COMPASS Pathways
Sheppard Pratt Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Between 18 and 65 years of age at Screening * Diagnosis of Major Depressive Disorder (MDD) * Significant level of suicidal thoughts with active ideation and without immediate intent * Failure to respond to 2 medications in the current episode
Exclusion criteria
* Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc. * Current alcohol or substance use disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Scale for Suicidal Ideation (MSSI) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Åsberg Depression Rating Scale (MADRS) | 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) | 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. |
| Concise Health Risk Tracking Self Report 12 Items (CHRT-SR) | 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) | 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. |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), and Week 12 (V10) | 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. |
| Clinical Global Impression - Modified for Depression (CGI-D) | Baseline (V2) to Week 3 (V7) and Week 12 (V10) | The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response. |
| Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI) | Baseline (V2) to Week 3 (V7), and Week 12 (V10) | The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response. |
Countries
United States
Outcome results
None listed