R33: Levetiracetam in Early Psychosis

Early Psychosis Clinical Trial

Official title: A 12-week Randomized, Double-blind, Placebo-controlled Trial Investigating the Effects of Levetiracetam in Early Psychosis

Status Recruiting

Clinical Trial Summary

This is a 12-week study of levetiracetam added to a second generation antipsychotic in early psychosis patients who have been ill for less than 5 years and continue to experience psychotic symptoms despite at least 8 weeks of antipsychotic treatment. Levetiracetam (Keppra) is a medication approved for the treatment of epilepsy; it reduces excessive activity in the brain. This study will test the hypotheses that adding levetiracetam will improve psychotic symptoms that are unresponsive to antipsychotic treatment and will protect the brain from atrophy (volume loss). .

Clinical Trial Description

Participants will complete screening and baseline visits before being randomized in a 2:1 ratio to levetiracetam or placebo added to the antipsychotic medication. They will complete weekly study visits for the first 4 weeks (Baseline, Weeks 2-4) and then additional visits at Week 6, 8, and 12. Participants will be studied both by assessing change in symptom severity and cognitive performance over the 12 weeks as well as using an imaging measure of hippocampal volume integrity at baseline and week 12. After completing Week 12 or decision to withdraw prematurely from the study, participants will complete a 9 day medication tapering regimen. ;

Related Conditions & MeSH terms

• Early Psychosis
• Mental Disorders
• Psychotic Disorders

• NCT number: NCT04317807
• Study type: Interventional
• Source: NYU Langone Health
• Contact: Gillian Capichioni
• Phone: 917-628-0552
• Email: gillian.capichioni@nyulangone.org
• Status: Recruiting
• Phase: Phase 2
• Start date: August 27, 2020
• Completion date: January 2025