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Psilocybin for Depression
Study Summary
This trial is exploring whether a 25mg dose of psilocybin is safe and effective in treating cancer patients with depression.
- Depression
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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- Your depression score is 18 or higher during the screening and baseline assessments.Your personal circumstances or behavior make it difficult to build a trusting relationship or safely use psilocybin.You are currently receiving or have recently received chemotherapy or radiation therapy that affects your overall physical ability.You have signed the informed consent form.You have used drugs like psilocybin (magic mushrooms) or other psychedelics, except for medical marijuana, within the last year. Additionally, you have used psychedelics during your current episode of depression.You are able to understand and agree to participate in the study, as determined by the investigator.You must be 18 years or older during the first screening of the trial.Your depression level is high, as measured by the HAM D 17 score, during screening and baseline visits.You will be excluded if you have a history of certain psychiatric conditions.You have had thoughts of suicide or have engaged in suicidal behaviors within the past year, or a doctor has determined that you are at high risk for suicide based on your interview with them.You are not taking antidepressant, antipsychotic medications or medical cannabis during the screening process.You have a condition that causes seizures.You have been diagnosed with cancer as classified by ICD-10 codes C00 to C97.You have been diagnosed with major depression and it has been documented by a doctor or mental health professional.Your diabetes is not well controlled or you need to take insulin to manage it.You have been diagnosed with certain mental health conditions like schizophrenia, bipolar disorder, or borderline personality disorder.
- Group 1: Psilocybin 25mg
- 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
How many study participants are part of this research project?
"Presently, this study is not admitting new patients. The clinical trial was first announced on September 1st, 2020 and has had one update since then on October 14th, 2021. For individuals looking for other studies, there are 2117 trials for major depressive disorder (mdd) and 37 psilocybin studies Currently enrolling participants."
Has the FDA cleared psilocybin for therapeutic use?
"While there is some evidence suggesting that Psilocybin is safe, it only received a score of 2 because there is no data currently supporting its efficacy."
Are there any other ongoing trials that involve Psilocybin?
"Psilocybin is being studied in 37 different clinical trials, with the majority of research based out of Vancouver, Washington. 0 of these studies are currently in Phase 3. Psilocybin clinical trials can be found at 40 locations across the globe."
Are people with the required medical conditions still able to sign up for this research project?
"Unfortunately, this research is no longer recruiting patients. Although, according to the latest update on October 14th 2021, if you are seeking other studies there are 2117 trials actively admitting participants with major depressive disorder (mdd) and 37 studies for Psilocybin actively recruiting participants."
Who else is applying?
What state do they live in?
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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?
Average response time
- < 1 Day
Typically responds via
Most responsive sites:
- Maryland Oncology Hematology PA: < 24 hours
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