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A Study of Psilocybin for PTSD - Trial NCT06407635

Access comprehensive clinical trial information for NCT06407635 through Pure Global AI's free database. This Phase 1 trial is sponsored by Johns Hopkins University and is currently Not yet recruiting. The study focuses on Post Traumatic Stress Disorder. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06407635
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06407635
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A Study of Psilocybin for PTSD
Psilocybin for PTSD With or Without Psychotherapy: A Pilot Study of Safety and Efficacy

Study Focus

Psilocybin

Interventional

drug

Sponsor & Location

Johns Hopkins University

Timeline & Enrollment

Phase 1

May 01, 2024

May 01, 2027

20 participants

Primary Outcome

Incidence of Adverse Events,Columbia Suicide Severity Rating Scale (C-SSRS),Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5),Ecological Momentary Assessment (EMA) of PTSD Checklist for DSM-5 (PCL-5),World Health Organization Quality of Life Brief Version (WHOQOL-BREF)

Summary

The proposed open-label, controlled study at the Johns Hopkins Center for Psychedelic and
 Consciousness Research (CPCR) will test the following primary hypotheses in adult patients
 with chronic PTSD who are currently taking a serotonin reuptake inhibitor: psilocybin therapy
 will be feasible and safe for participants, significantly remediate PTSD symptoms, and
 enhance wellbeing and quality of life. In addition, the study will examine whether elements
 of evidence-based trauma-focused psychotherapy enhance treatment response when paired with
 psilocybin.

ICD-10 Classifications

Post-traumatic stress disorder
Traumatic shock
Personal history of psychological trauma, not elsewhere classified
State of emotional shock and stress, unspecified
Neurotic, stress-related and somatoform disorders

Data Source

ClinicalTrials.gov

NCT06407635

Non-Device Trial