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.
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
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
20
10 mg or 25 mg oral aqueous psilocybin solution
Halucenex Life Sciences Inc.
Windsor, Nova Scotia, Canada
Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess
This is a 42 item questionnaire assessing patient-rated subjective intensity of psilocybin's effects
Time frame: Day 14
PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
Total CAPS-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
Time frame: Screening to 12 months follow up
PTSD symptom severity as measured by the Posttraumatic Checklist for the DSM-5 (PCL-5)
Total PCL-5 Scores range from 0-80. Higher scores indicate greater symptom severity.
Time frame: Screening to 12 months follow up
Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).
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).
Time frame: Screening to 12 months follow up
Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).
The 90 items in the SC90-R are assessed by the subject using a 5-point rating scale.
Time frame: 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).
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").
Time frame: Day 22
Anxiety as measured by the Beck Anxiety Inventory (BAI).
The BAI is a 21-item self-report inventor. Total BAI Scores range from 0-63; higher scores indicate more severe anxiety.
Time frame: Up to 12 month follow up
Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).
The STAI-T scale consists of 20 items on a 4-point scale; Higher scores indicate greater anxiety.
Time frame: Up to 6 month follow up
Depression as measured by the Beck Depression Inventory (BDI).
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.
Time frame: Up to 12 month follow up
Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).
The QIDS-SR contains 16 items, with each item scored from 0 to 3.
Time frame: Up to 12 month follow up
Impairments in daily living as measured by the Sheehan Disability Scale (SDS).
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").
Time frame: Up to 12 month follow up
Body Mass Index (BMI)
Measure of body mass based on height and weight
Time frame: Up to 12 month follow up
Trauma Related Nightmare Survey
trauma-focused survey to track sleep and nightmare-related information
Time frame: Up to 12 month follow up
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