This non-randomized, single-group assignment trial (n=50) aims to investigate the glutamatergic mechanisms of psychosis and target engagement using ketamine hydrochloride in healthy volunteers.
The study, conducted by the New York State Psychiatric Institute, involves 2 identical ketamine-induced pharmacoBOLD (phBOLD) sessions at least 7 days apart. Ketamine doses will be assigned in successive 10 subject cohorts, starting at 0.08 mg/kg, with subsequent doses adjusted to determine the lowest dose that still produces a robust phBOLD response.
Participants will undergo MRI scans and clinical assessments, with the primary outcome measures being the phBOLD response to ketamine and changes in the Brief Psychiatric Rating Scale (BPRS) scores. The study aims to develop phBOLD as a biomarker for glutamatergic treatment development and explore mechanisms of psychosis. It started on January 1, 2021, and is estimated to be completed by February 1, 2025.
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New York State Psychiatric InstituteThe New York State Psychiatric Institute (NYSPI), established in 1895, was one of the first institutions in the United States to integrate teaching, research and therapeutic approaches to the care of patients with mental illnesses.