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-naïve 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.
Phase:
Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health