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

Brief description of study

This is a 12-week study of levetiracetam in conjunction with a second generation antipsychotic in early psychosis patients with treatment-resistant symptoms. Treatment with antipsychotics has been shown to be associated with loss of volume in the hippocampus. Brain chemicals, called neurotransmitters, that might be associated with this loss are glutamate and dopamine. The drug levetiracetam reduces excessive amounts of these neurotransmitters, which may help protect against this loss when taken with antipsychotics. Participants will complete screening and baseline visits before being randomized in a 2:1 ratio of levetiracetam or placebo. 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 a 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.


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


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