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

NCT ID: NCT05220410

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2025-05-12

Brief Summary

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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

Detailed Description

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Conditions

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Treatment Resistant Depression Suicidal Ideation

Keywords

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Psilocybin Psychedelic Major depression Treatment resistant depression Suicidal ideation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin

25mg of Psilocybin

Group Type EXPERIMENTAL

Psilocybin

Intervention Type DRUG

Open-Label

Interventions

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Psilocybin

Open-Label

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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COMPASS Pathways

INDUSTRY

Sponsor Role collaborator

Sheppard Pratt Health System

OTHER

Sponsor Role lead

Responsible Party

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Scott T. Aaronson, M.D

Director, Clinical Research Programs

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Scott Aaronson, MD

Role: PRINCIPAL_INVESTIGATOR

Sheppard Pratt Health System

Locations

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Sheppard Pratt Health System

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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49348

Identifier Type: -

Identifier Source: org_study_id