Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia

  • End date
    Dec 27, 2023
  • participants needed
  • sponsor
    University of Colorado, Denver
Updated on 27 April 2022
schizoaffective disorder


Levetiracetam (LEV: (S)-α-ethyl-2-oxo-pyrrolidine acetamide) is an anticonvulsant/antiepileptic drug. The specific aim of this study is to assess the efficacy of low-dose LEV in reducing hippocampal activity in schizophrenia. The investigators also hypothesize that LEV will improve neurocognition in participants with schizophrenia.


LEV is typically administered in twice-daily doses of 500-1500 mg for the treatment of epilepsy; these doses are generally well tolerated (Patsalos, 2000). Most relevant to the proposed study, LEV (125 mg twice-daily, two week administration) has been shown to reduce hippocampal hyperactivity and improves cognition in patients with mild cognitive impairment (MCI).

The proposed study will administer 125 mg of immediate release LEV twice-daily for two weeks. This dose was chosen to potentially maximize efficacy while minimizing side effects. The proposed dose is substantially lower than the most common dose used clinically for epilepsy treatment of 3000 mg/day.

Condition Schizophrenia
Treatment Placebo, Levetiracetam
Clinical Study IdentifierNCT02647437
SponsorUniversity of Colorado, Denver
Last Modified on27 April 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of schizophrenia or schizoaffective disorder
Good general health
Normal vital signs (blood pressure, pulse, cardiac, pulmonary, abdominal, neurological exam)
Normal renal function (as assessed by a metabolic panel at screening if results current within three months are not already available)

Exclusion Criteria

Substance abuse
Significant neurological disorders
Significant head trauma/injury
MRI-specific exclusion criteria (e.g., claustrophobia, weight > 450lbs, metal in the body)
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