R33: Levetiracetam in Early Psychosis

PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

August 27, 2020

Primary Completion Date

April 1, 2025

Study Completion Date

April 10, 2025

Conditions
Early Psychosis
Interventions
DRUG

Levetiracetam Pill

Levetiracetam is an anticonvulsant that is frequently used to treat epilepsy in children and adults due to its superior tolerability, ease of use and excellent safety profile. It is rapidly absorbed and rapidly crosses the blood-brain barrier. Levetiracetam does not affect metabolism of antipsychotic drugs and may normalize hippocampal hyperactivity by decreasing excessive glutamatergic and dopaminergic transmission, thereby making it an ideal agent to test the hypothesis that reducing excessive hippocampal activity may enhance treatment of early psychosis and prevent antipsychotic toxicity. Levetiracetam will be administered in 500 mg capsules twice a day.

OTHER

Placebo

The placebo pill (sugar pill) will look just like the levetiracetam pill but does not contain levetiracetam. Placebo will be taken along with optimal antipsychotic medication selected by either the outpatient provider or the hospital staff responsible for the participant's care. Participants will be instructed to take the placebo pill twice daily for 12 weeks.

Trial Locations (1)

10016

NYU Langone Health, New York

All Listed Sponsors
lead

NYU Langone Health

OTHER

NCT04317807 - R33: Levetiracetam in Early Psychosis | Biotech Hunter | Biotech Hunter