A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of a Single Administration of COMP360 in Participants with Treatment-Resistant Depression
Efficacy and Safety of COMP360 as Treatment for Treatment-Resistant Depression
Sponsor: COMPASS Pathways Ltd.
Enrolling: Male and Female Patients
Study Length: 16 Weeks
Clinic Visits: 8
IRB Number: 8402
Contact: Alexandra Mackay: 646-774-8027 / alexandra.mackay@nyspi.columbia.edu
Additional Study Information: We are currently enrolling adult individuals with treatment-resistant depression (TRD) for this research study. This study is investigating a new treatment approach for people with TRD using an investigational medicine (psilocybin) given with psychological support. Psilocybin is the active ingredient in some forms of psychedelic mushrooms and its effects can include euphoria, visual hallucinations, changes in perception, a distorted sense of time, and spiritual experiences. This study is suitable for people who are currently experiencing a recurrent or single episode of depression, but who have not responded to antidepressant treatment. The study may last up to 16 weeks and study visits will include physical examination, vital signs, electrocardiograms, blood collection, urine collection, and psychological assessments. Participants will be divided into two groups and randomly (by chance, like the flip of a coin) allocated to receive either psilocybin or placebo. Neither the participants nor the study staff will be told which treatment, psilocybin or placebo, participants received.
David Hellerstein, MD
Do You Qualify?
Are you currently depressed? Yes No
Have you tried two or more treatments for your current episode of depression that have not reduced your depressive symptoms? Yes No
Would you be willing to come off prohibited treatments, including any current antidepressant treatment, as part of the study? Yes No
Have you been a psychiatric inpatient in the past 12 months? Yes No
You may be eligible for this study

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For more information, please contact:
Alexandra Mackay