NCT03129360

Levetiracetam in Early Psychosis

A Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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 EP subjects.

Conditions

• Psychosis
• Schizophrenia
• Schizo Affective Disorder
• Schizophreniform

Interventions

Type	Name	Description
DRUG	Levetiracetam	Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
DRUG	Placebo	Prepared in capsules to appear identical to levetiracetam.

Timeline

• Start date: 2017-08-18
• Primary completion: 2021-11-03
• Completion: 2021-11-03
• First posted: 2017-04-26
• Last updated: 2022-11-21
• Results posted: 2022-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study