- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05243329
Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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. These selective serotonin reuptake inhibitors (SSRIs) have limited efficacy. Furthermore, there is a lack of efficacious pharmacotherapy for treatment-resistant PTSD; PTSD remains a chronic and sometimes debilitating condition. New research into other treatment options for PTSD are warranted.
Psychedelic medications, including psilocybin, have recently received breakthrough designation by the US Food and Drug Administration (FDA) for other psychiatric indications. Psilocybin has received breakthrough designation for treatment of depression. Research on psilocybin has shown that it facilitates fear extinction in mice and promotes neuroplasticity, increasing neurogenesis, spinogenesis and synaptogenesis. These properties may contribute to antidepressive and anxiolytic effects. Psilocybin also reduces activity in the amygdala during threat responses; decreased amygdala reactivity is correlated with positive mood. This is particularly relevant since individuals with PTSD showed increased reactivity in the amygdala, which may increase the ability to process traumatic memories. 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Nova Scotia
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Windsor, Nova Scotia, Canada, B0N2T0
- Halucenex Life Sciences Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
- Subjects must be ≥18 and ≤70 years of age.
- Subjects must meet the Diagnostic & Statistical Manual of Mental Disorders - Version V (DSM-V) criteria for TR-PTSD.
- 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).
- 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:
- 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).
- Uncontrolled hypertension or BP ≥140/90 mmHg over 2 days, with at least 4 BP assessments completed.
- 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.
- 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.).
- 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.
- Blood draw or needle phobia.
- Suicidal attempt or active ideation deemed to present risk of suicide as judged by study clinical staff in past 30 days..
- BMI <14 or >42 or the Qualified investigator deems the patient sufficiently healthy to participate.
- 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.
- Any uncontrolled eating disorder (e.g., purging or anorexia or worsening of directionally undesirable weight change of 5 kg in past 30 days).
- Subjects with a diagnosis of DSM-5 personality disorder which has a major impact on the subject's current psychiatric status
- Use of any investigational drug, hallucinogen, or ketamine/esketamine within the past 30 days, or plan to use during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psilocybin treatment for treatment-resistant PTSD
Experimental Treatment: Experimental: Psilocybin 10mg (low dose) on Day 7 25mg (high dose) on Day 14 10mg dose (optional top-up low dose) at Month 7 Treatment Description: Drug: Psilocybin drug product suspension Psilocybin is manufactured as a bulk API powder. The psilocybin drug product suspension is prepared by a compounding pharmacist at the clinic site. The psilocybin drug product suspension will be mixed in a glass with water to produce the psilocybin solution for oral consumption. Subjects will be instructed to orally consume the study medication in the glass in its entirety. Psilocybin will be administered in the following doses and at the following time points for this study:
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10 mg or 25 mg oral aqueous psilocybin solution
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess
Time Frame: Day 14
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This is a 42 item questionnaire assessing patient-rated subjective intensity of psilocybin's effects
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Day 14
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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).
Time Frame: Day 22
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The CGI-S scale is a 7-point, clinician-rated scale (ranging from 1 to 7, with 1 indicating a "normal state" and 7 indicating "among the most extremely ill patients").
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Day 22
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PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
Time Frame: Screening to 12 months follow up
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Total CAPS-5 Scores range from 0-80.
Higher scores indicate greater symptom severity.
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Screening to 12 months follow up
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PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)
Time Frame: Screening to 12 months follow up
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Total PCL-5 Scores range from 0-80.
Higher scores indicate greater symptom severity.
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Screening to 12 months follow up
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Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).
Time Frame: Screening to 12 months follow up
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The IES-R is a 22-item self-report measure where respondents are asked to identify a specific stressful life event and then indicate how much they were distressed or bothered during the past seven days by each "difficulty" listed.
Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").
The IES-R yields a total score (ranging from 0 to 88).
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Screening to 12 months follow up
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Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).
Time Frame: Screening to 12 months follow up
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The 90 items in the SC90-R are assessed by the subject using a 5-point rating scale.
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Screening to 12 months follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).
Time Frame: Up to 6 month follow up
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The STAI-T scale consists of 20 items on a 4-point scale; Higher scores indicate greater anxiety.
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Up to 6 month follow up
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Anxiety as measured by the Beck Anxiety Inventory (BAI).
Time Frame: Up to 12 month follow up
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The BAI is a 21-item self-report inventor.
Total BAI Scores range from 0-63; higher scores indicate more severe anxiety.
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Up to 12 month follow up
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Depression as measured by the Beck Depression Inventory (BDI).
Time Frame: Up to 12 month follow up
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The BDI is a 21-item, self-report rating inventory with each item scored on a scale value of 0 to 3; higher total scores indicating more severe depression symptoms.
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Up to 12 month follow up
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Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
Time Frame: Up to 12 month follow up
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The QIDS-SR contains 16 items, with each item scored from 0 to 3.
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Up to 12 month follow up
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Impairments in daily living as measured by the Sheehan Disability Scale (SDS).
Time Frame: Up to 12 month follow up
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This is a 3-item, clinician administered questionnaire with all items rated on an 11-point continuum, with higher scores indicating more severe impairment.
(0 meaning "no impairment" to 10 meaning "most severe").
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Up to 12 month follow up
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Body Mass Index (BMI)
Time Frame: Up to 12 month follow up
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Measure of body mass based on height and weight
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Up to 12 month follow up
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Trauma Related Nightmare Survey
Time Frame: Up to 12 month follow up
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trauma-focused survey to track sleep and nightmare-related information
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Up to 12 month follow up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Lisa Batten, PhD, Halucenex Life Sciences
- Principal Investigator: Paige Stevens, MD, Contracted
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22HLCPP01/HCX-2020-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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