Ohio State University
The goal of this study is to learn how psychedelics may help symptoms of depression and anxiety. Participants with major depressive disorder experiencing symptoms of depression and anxiety will receive one dose of either a drug related to psilocybin or a placebo. Assessments include interviews, self-report questionnaires, EEG and fMRI to measure symptoms and brain function.
Many patients with MDD do not respond or have an incomplete response to treatment with currently available antidepressants. The use of psychedelics (e.g. psilocybin) is being investigated as a new approach to improve depressive symptomatology, however their mechanism of action is still not well understood. Psilocin is the active metabolite of psilocybin responsible for the psychedelic effects of the parent compound. CYB003 is a synthetic, deuterated isotopomer of psilocin, being developed by Cybin for the treatment of MDD. The study will investigate the changes in brain activity, connectivity,…
Inclusion Criteria: * Participant is assigned female or male at birth. * Participant is aged between 21 to 65 years, inclusive, at Screening. * Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening. * Participant is ≥60 kg. * Participant has a diagnosis of MDD (as defined in the DSM-5 established through a clinician interview that includes the Mini-International Neuropsychiatric Interview) * Depression severity moderate to severe based on MADRS score ≥21. * Anxiety severity moderate to severe based on GAD-7 ≥10. * Inadequate response to current antidepressant medication in current…
synthetic, deuterated isotopomer of psilocin
Placebo orange drink solution
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