A 12-week randomized double-blind placebo-controlled trial investigating the effects of levetiracetam in early psychosis

Brief description of study

The purpose of this study is to determine whether adding levetiracetam to usual medication treatment improves outcomes in early psychosis by protecting a part of the brain known as the hippocampus. Levetiracetam is a commonly used medication approved by the U.S. Food and Drug Administration (FDA) for use in epilepsy. Levetiracetam (brand name, Keppra) works by reducing excessive brain activity that causes epilepsy. The FDA has not approved levetiracetam for use in people with early psychosis. Therefore, it is considered investigational in this study. Participants will take either levetiracetam or placebo twice daily alongside their second-generation antipsychotic prescribed by their psychiatric provider. The study involves 9 visits over the course of 14 weeks. All subjects will receive a comprehensive psychiatric and medical evaluation and optimal clinical treatment as part of participation by Dr. Goff. It is possible that participants randomized to levetiracetam may experience improvements in their psychosis, although this potential benefit has not been established by prior research.

Clinical Study Identifier: s19-01820
ClinicalTrials.gov Identifier: NCT04317807
Principal Investigator: Donald C Goff.

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