A Mechanistic Study to Assess a Single Dose of CYB003 in Participants with Depression and Anxiety

This randomised, triple-blind, placebo-controlled trial (n=40) will investigate the effects of psilocin (16mg oral; CYB003) on brain activity and connectivity in individuals with major depressive disorder (MDD) and moderate to severe anxiety.

The study, sponsored by Ohio State University and led by Dr Kinh Luan Phan, aims to explore the underlying mechanisms of CYB003 by using functional magnetic resonance imaging (fMRI), electroencephalography (EEG), and electromyography (EMG) to measure changes in brain function before and after administration.

Participants will be randomly assigned to receive either CYB003 or a placebo and will undergo assessments at baseline, 24 hours, and 21 days post-treatment. Psychological support will be provided throughout the study. Key outcomes include changes in depression and anxiety symptoms, cognitive function, and psychedelic effects, assessed through clinician-rated scales and self-report questionnaires. The trial is expected to run from March 2025 to November 2027 at Ohio State University.

Topic Depression Anxiety Neuroscience
Compound Psilocybin Placebo
Country United States of America
Visit trial
Status Not yet recruiting
Results Published No
Start date 01 March 2025
End date 01 November 2027
Phase Phase II
Design Blinded
Type Interventional
Generation Second
Participants 40
Sex All
Age 21- 65
Therapy No

Trial Details

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.

Trial Number NCT06820723

Sponsors & Collaborators

Ohio State University
The Center for Psychedelic Drug Research & Education (CPDRE) at the College of Social Work at Ohio State University aims to explore and advance the research about psychedelic drugs and their effects, and to disseminate the knowledge about psychedelics.

Data attribution

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