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The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

Primary Purpose

Treatment Resistant Depression, Suicidal Ideation

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
Sheppard Pratt Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Psilocybin, Psychedelic, Major depression, Treatment resistant depression, Suicidal ideation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sheppard Pratt Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Psilocybin

Arm Description

25mg of Psilocybin

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
January 21, 2022
Last Updated
April 15, 2023
Sponsor
Sheppard Pratt Health System
Collaborators
COMPASS Pathways
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1. Study Identification

Unique Protocol Identification Number
NCT05220410
Brief Title
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Official Title
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheppard Pratt Health System
Collaborators
COMPASS Pathways

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression, Suicidal Ideation
Keywords
Psilocybin, Psychedelic, Major depression, Treatment resistant depression, Suicidal ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Psilocybin
Arm Type
Experimental
Arm Description
25mg of Psilocybin
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
Open-Label
Primary Outcome Measure Information:
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
All Visits - Baseline (Day -1 [V2]) to Week 12 (V10)
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale (MADRS)
Description
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.
Time Frame
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)
Title
Clinical Global Impression - Modified for Depression (CGI-D)
Description
The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
Time Frame
Baseline (V2) to Week 3 (V7) and Week 12 (V10)
Title
Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)
Description
The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
Time Frame
Baseline (V2) to Week 3 (V7), and Week 12 (V10)
Title
Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)
Description
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.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Shoultz
Phone
(410) 938-5263
Email
IADTclinicaltrialinquiries@sheppardpratt.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Swartz
Phone
(410) 938-3139
Email
IADTclinicaltrialinquiries@sheppardpratt.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Aaronson, MD
Organizational Affiliation
Sheppard Pratt Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppard Pratt Health System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey Shoultz
Phone
410-938-5263
Email
IADTclinicaltrialinquiries@sheppardpratt.org
First Name & Middle Initial & Last Name & Degree
Scott T Aaronson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

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