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.
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic 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
Condition or Disease
- Treatment Resistant Depression
- Suicidal Ideation
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 20 (ESTIMATED) |
| Funded by: | Other|Industry |
| Allocation: | N/A |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Mar 28, 2022 | ACTUAL |
|---|---|---|
| Primary Completion: | May 01, 2023 | ESTIMATED |
| Completion Date: | Jan 01, 2024 | ESTIMATED |
| Study First Posted: | Feb 02, 2022 | ACTUAL |
| Last Updated: | Apr 15, 2023 |
Sponsors / Collaborators
Lead Sponsor:
Sheppard Pratt Health System
Responsible Party:
N/A
Location
Participant Groups
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25mg of Psilocybin
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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
* 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
This clinical trial is recruiting
Are you interested in participating in this trial or others? We'd love to help.
Primary Outcomes
Secondary Outcomes
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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.
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The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
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The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
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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.
More Details
| NCT Number: | NCT05220410 |
|---|---|
| Other IDs: | 49348 |
| Study URL: | https://clinicaltrials.gov/study/NCT05220410 |
Last updated: Sep 29, 2023