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Unknown statusPhase 2

Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder

NCT05243329 · Halucenex Life Sciences Inc.

Closed to entry
Status
Not accepting participants
Phase 2
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

Post-traumatic stress disorder (PTSD) is a complex disorder expressed as a variety of neurobiological symptoms, including anxiety, re-experiencing, hyperarousal, and avoidance symptoms, along with comorbidities such as anxiety, depression, and increased risk for self-medicating substance abuse. Currently, there are only two approved medications in the United States (US) for PTSD, paroxetine and sertraline. Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Although no formal clinical trials have yet investigated psychedelic substances for the treatment of PTSD, the available evidence warrants such an investigation. The present study aims to investigate the effect of psilocybin on treatment-resistant PTSD.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess

    Measured over Day 14

  • PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)

    Measured over Screening to 12 months follow up

  • PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)

    Measured over Screening to 12 months follow up

  • Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).

    Measured over Screening to 12 months follow up

  • Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).

    Measured over Screening to 12 months follow up

  • Symptom severity, treatment response, and the efficacy of treatment studies of patients with mental disorders as measured by the Clinical Global Impression - Improvement (CGI-I)/ Clinical Global Impression - Severity (CGI-S).

    Measured over Day 22

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: \- After signing and dating the informed consent documents, subject eligibility will be assessed. Subjects must meet the following criteria to be eligible for enrollment into the study. 1. Subjects must be ≥18 and ≤70 years of age. 2. Subjects must meet the Diagnostic \& Statistical Manual of Mental Disorders - Version V (DSM-V) criteria for TR-PTSD. 3. Subjects must have treatment-resistant PTSD symptoms, defined as a CAPS score of ≥30 (signifying moderate to severe symptoms) following at least 3 months of prior SSRI or serotonin-norepinephrine reuptake inhibitor (SNRI) treatment in addition to at least 4 months of psychotherapy (adapted from Mithoefer et al, 2011). 4. Subjects must be able to communicate in English. Exclusion Criteria: * Subjects meeting any of the following criteria will not be eligible for participation in the study: 1. Pregnant individuals and those of childbearing age not using effective contraception (e.g., oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, or barrier method). 2. Uncontrolled hypertension or BP ≥140/90 mmHg over 2 days, with at least 4 BP assessments completed. 3. In the clinical judgement of the investigator, any hazard-posing medical, emotional, or significant character disorder or condition rendering unsuitability for the study. For example, poorly controlled diabetes, severe cardiovascular disease, seizure disorders, sleep apnea disorders (suspected or ineffectively treated), untrustworthiness, suicidality, etc. 4. Any use of methamphetamines or any injection drug abuse in the past 30 days and/or a positive test for drugs of abuse (e.g., cocaine, amphetamines, opiates, benzodiazepines, etc.). 5. Any other significant substance use disorder that may interfere with study objectives including consuming \>5 cups of caffeinated coffee a day or inability, without discomfort, to refrain from smoking cigarettes or cannabis, or consuming alcohol for 7 hours. 6. Blood draw or needle phobia. 7. Suicidal attempt or active ideation deemed to present risk of suicide as judged by study clinical staff in past 30 days.. 8. BMI \<14 or \>42 or the Qualified investigator deems the patient sufficiently healthy to participate. 9. Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or obsessive-compulsive disorder. 10. Any uncontrolled eating disorder (e.g., purging or anorexia or worsening of directionally undesirable weight change of 5 kg in past 30 days). 11. Subjects with a diagnosis of DSM-5 personality disorder which has a major impact on the subject's current psychiatric status 12. Use of any investigational drug, hallucinogen, or ketamine/esketamine within the past 30 days, or plan to use during the study.

Where

1 study site

FacilityCityRegionCountry
Halucenex Life Sciences Inc.WindsorNova ScotiaCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05243329 on ClinicalTrials.gov →

Last updated in the registry 2023-06-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits