RecruitMe Clinical Trial

The Safety and Efficacy of Psilocybin in Participants with Treatment-Resistant Depression (TRD)
Psilocybin for treatment of depression
Sponsor:COMPASS Pathways
Enrolling:Male and Female Patients
Age Range:Between 18 and 55 years old
IRB Number:7719
U.S. Government ID:NCT03775200
Contact: Peter Arden, Depression Evaluation Service, NY State Psychiatric Institute: 646-774-8004 / peter.arden@nyspi.columbia.edu
Additional Study Information:

Psilocybin is the active ingredient in some forms of psychedelic mushrooms. Its effects can include euphoria, visual hallucinations, changes in perception, a distorted sense of time and spiritual experiences. Adverse events can include headaches, rapid heart beat, increased blood pressure, nausea and panic attacks. All of these effects generally last minutes to hours, though perceptual changes occasionally recur to a lesser and lesser extent as they dissipate over several weeks. Early reports of anecdotal and unsupervised use of "magic mushroooms" leading to repeated "flashbacks" months and years later or other continuing adverse experiences have not been substantiated in more recent systematic observations of psilocybin use. A recent open label (that is, there was no placebo or other comparison group) study suggested that a single dose of psilocybin could significantly improve depressive symptoms within hours with improvements lasting during three month follow-up. Thus, a double-blind, placebo-controlled study seems indicated. Especially since the only known treatment that relieves depression and its attendant symptoms within hours is ketamine, while ketamine's effects seem to last only hours to days, a single dose treatment whose effects might last at least for several months is appealing. This company sponsored multisite, international study proposes to randomly assign 216 adults aged 18 and older with treatment resistant depression to a single dose of psilocybin (1 mg, 10 mg or 25 mg), then follow subjects for three months. On the day prior to psilocybin administration, the subjects will meet with a therapist who has been specially trained to help patients adjust to psilocybin's effects. For about six hours (longer if needed) on the psilocybin administration day, the therapist will sit with the patient and ease their experience.

Do You Qualify?
Have you been significantly depressed for at least 3 months?YesNo
Have you been treated with at least 2 antidepressant medications but not responded?YesNo
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Investigator
David Hellerstein, MD
You may be eligible for this study

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Who Can I Contact?
For more information, please contact:
Peter Arden, Depression Evaluation Service, NY State Psychiatric Institute
Email: peter.arden@nyspi.columbia.edu
Phone: 646-774-8004