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Psilocybin for Post-Traumatic Stress Disorder
This trial will test whether psilocybin can help treat PTSD in military veterans.
- Post Traumatic Stress Disorder
- Trauma and Stressor Related Disorders
- Psychiatric Disorder
- Post-Traumatic Stress Disorder
- Traumatic Stress Disorders
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Side effects dataFrom 2021 Phase 2 trial • 95 Patients • NCT02061293
Awards & Highlights
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Who is running the clinical trial?
- You have been diagnosed with schizophrenia, bipolar I or II disorder or any other similar mental illness in the past or currently.You are between 21 and 64 years old.You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) according to the DSM-5.You have a history of a suicide attempt that was serious and required medical attention.You have not used hallucinogenic drugs frequently in your lifetime.You have served in the US military.You have heart or blood vessel conditions.You have diabetes that requires insulin treatment.You are a former member of the US military.You are between 21 and 64 years of age.Your symptoms are very severe and you have a score of 35 or higher on a test that measures the severity of your condition.You have at least a high-school level of education or equivalent.You have been diagnosed with Post-Traumatic Stress Disorder (PTSD) according to a specific diagnostic manual called DSM-5.You must be in good overall health.You have a history of serious alcohol, tobacco or drug addiction within the past year.You have a mental health condition that makes it difficult to build a good relationship with your healthcare provider.You have heart or blood vessel problems.Your body weight is either significantly higher or lower than what is considered ideal.You have had a problem with drinking alcohol, smoking tobacco, or using drugs in the past year.You have a close family member (like a parent, sibling, or grandparent) who has schizophrenia, bipolar disorder, or other similar mental health conditions.You have a history of a serious suicide attempt.You have only used hallucinogenic drugs a few times in your life.You have a history of seizures caused by epilepsy.You are currently taking medication for mental health issues.You are significantly underweight or overweight (more than 25% outside the ideal range for your height).You are currently taking antidepressant medication.You have a score of 35 or higher on a test that measures the severity of your symptoms.You have diabetes that requires insulin for management.You are currently taking medication for mental health.Your close family member (parent, sibling, grandparent, aunt/uncle) has been diagnosed with schizophrenia, bipolar disorder type 1 or type 2, or any other psychotic disorder.You have a history of seizures due to epilepsy.You have been diagnosed with schizophrenia, other psychotic disorders, or bipolar disorder.
- Group 1: Psilocybin-assisted therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is participation in this clinical study confined to individuals aged 75 and under?
"Prospective participants of this trial must be between the ages 21 and 64. For those younger or elder, there are 365 trials available to minors and 1033 options that cater to patients above the age of 65."
Are there still opportunities to enroll in this clinical research endeavor?
"Clinicaltrials.gov indicates that this medical study, which began recruiting on January 1st 2023 and last updated its records on September 21st 2022 is not presently searching for participants. However, there are currently 1504 other clinical trials actively seeking candidates at the moment."
Is it possible for me to be a participant in this trial?
"This research seeks to recruit 15 individuals, aged 21-64, who have suffered moral injury and fulfill the following requirements: no antidepressant treatment history prior to enrollment; minimal risk of suicidal behaviour as judged by the study clinicians; veteran status within the US military; high school education or equivalent; current DSM-5 diagnosis of Post-Traumatic Stress Disorder (PTSD); CAPS-5 total severity score ≥35 at baseline assessment point; medically stable condition; limited lifetime experience with hallucinogens; and general medical health."
To what extent is Psilocybin-assisted therapy hazardous for individuals?
"Considering the current dataset, our team at Power gave Psilocybin-assisted therapy a score of 2 out of 3. This is due to Phase 2 trial data which suggests that there are some safety measures in place but no efficacy evidence yet available."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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How responsive is this trial?
Typically responds via
Average response time
- < 2 Days
Most responsive sites:
- Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center: < 48 hours
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