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Completed

NCT Number: NCT05220410

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

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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Key information

Conditions

Treatment Resistant Depression Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psilocybin

Drug

Open-Label

Primary outcomes

  1. Modified Scale for Suicidal Ideation (MSSI)

    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)

    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 outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    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)

    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.

  2. Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)

    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)

    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.

  3. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: 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.

  4. Clinical Global Impression - Modified for Depression (CGI-D)

    Time frame: 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.

  5. Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sheppard Pratt Health System

Other

Collaborators

  • COMPASS Pathways

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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