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Psilocybin for Major Depressive Disorder - TRD
Study Summary
This trial studied if a drug is safe & effective for people with depression that hasn't responded to other treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below: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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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Media Library
- You have a history of certain personality disorders or ongoing serious mental health issues based on medical history and clinical judgement.You have been diagnosed with Borderline Personality Disorder or show symptoms of it as per medical records or a specific interview called "MINI plus - borderline personality disorder module".I have tried 2-4 different depression medications without success.I have used specific treatments for depression recently.I have depression that didn't improve after trying 2-4 different medications.My first major depression episode has lasted between 3 months and 2 years.Your depression needs to be moderate or severe, which will be determined by a score of 20 or higher on the MADRS test during screening and baseline evaluations.I am 18 years old or older.I have been diagnosed with major depression without psychosis.At the initial observation, you must agree to discontinue any disallowed medications.I am 18 years old or older.Your depression is moderate or severe, with a score of 20 or higher on a depression rating test.I have previously received COMP360 psilocybin therapy.My first major depression episode has lasted between 3 months and 2 years.I have been diagnosed with major depression without psychosis.
- Group 1: 25 mg COMP360 Psilocybin
- Group 2: 10 mg COMP360 Psilocybin
- Group 3: 1 mg COMP360 Psilocybin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 10 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 3 null
- Follow Ups: You may be asked to continue sharing information regarding the trial for 14 Weeks after you stop receiving the treatment.
Frequently Asked Questions
How many participants are currently taking part in this clinical research?
"Affirmative. Clinicaltrials.gov shows that, since its initial posting on February 1st 2023, this study is still actively seeking 568 individuals from 3 distinct medical centres to take part in the trial."
Is this experiment taking in more participants currently?
"Data accessible on clinicaltrials.gov reveals that this medical trial is still recruiting, having been posted February 1st 2023 and most recently updated January 25th 2023."
Has the FDA sanctioned 25 mg COMP360 Psilocybin for clinical application?
"There is prior clinical evidence verifying the safety of 25 mg COMP360 Psilocybin, thus affording it a score of 3."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Most responsive sites:
- Innovative Clinical Research, Inc.: < 24 hours
- Atlanta Center for Medical Research: < 24 hours
- The Ohio State University: < 24 hours
Typically responds via
Average response time
- < 2 Days
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