In order to establish target engagement and identify an effective dose the investigators will conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500 mg in 24 medication-nave early psychosis (EP) patients, measuring hippocampal activity by pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is calculated to achieve blood levels within the range that were associated with reduced hippocampal activity and improved cognition in patients with mild cognitive impairment; the higher dose is a typical antiepileptic dose. Successful demonstration of target engagement will be defined by an effect size of 0.5 or greater compared to placebo in reduction by levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse effects. The investigators will also study 8 healthy control subjects to verify that baseline hippocampal blood flow is elevated in the sample of FEP subjects.
| Condition | Schizophrenia and Schizoaffective Disorders, Schizophrenia, psychotic, schizoaffective disorder, psychotic disorders, schizophrenia disorders, Schizophrenia and Schizoaffective Disorders (Pediatric), Psychosis, Schizophreniform, psychotic disorder |
|---|---|
| Treatment | Levetiracetam |
| Clinical Study Identifier | NCT03129360 |
| Sponsor | NYU Langone Health |
| Last Modified on | 30 June 2022 |
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