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Psilocybin for PTSD
Study Summary
This trial will test whether psilocybin can help treat PTSD in military veterans.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 2 trial • 95 Patients • NCT02061293Trial Design
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Who is running the clinical trial?
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- I am between 21 and 64 years old.I use insulin to manage my diabetes.I have been diagnosed with PTSD.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 not used hallucinogenic drugs frequently in your lifetime.I am between 21 and 64 years old.I am currently pregnant.You have a history of a suicide attempt that was serious and required medical attention.I am currently taking medication that affects serotonin in my brain.I am currently taking medication that affects my brain's serotonin levels daily.My weight is more than 25% over or under the ideal range.You are a former member of the US military.I have not taken antidepressants before joining this study.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.I am currently taking antidepressants.I have epilepsy with a history of seizures.You have been diagnosed with schizophrenia, bipolar I or II disorder or any other similar mental illness in the past or currently.I have a heart condition.I am currently on medication for my mental health.A close family member has schizophrenia, bipolar disorder, or a similar condition.
- 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?
How many prior treatments have patients received?
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How responsive is this trial?
Typically responds via
Most responsive sites:
- Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center: < 48 hours
Average response time
- < 2 Days
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