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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
18
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Resting-state Neuronal Response
Mean neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest. This was measured as fractional amplitude of low frequency fluctuations (fALFF), which is a metric derived from resting-state fMRI that represents the power of regional spontaneous, intrinsic brain activity. This was calculated as the ratio of the low-frequency band power (0.01-0.1 Hz) to the total power across the entire frequency range of the Blood Oxygen Level-Dependent (BOLD) signal. Values generally range from 0 to 1, with higher values indicating a larger fraction of low-frequency fluctuations.
Time frame: 2 weeks
Neurocognitive Function
Cognitive function as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) cognitive test battery. The RBANS consists of 12 subtests; raw scores from the 12 subtests are converted into age-based standardized index scores (mean=100, standard deviation \[SD\]=15) across five cognitive domains (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). The five index scores are summed, then translated to a final total scale score (mean=100, SD=15) using the conversion table in the RBANS manual. RBANS total scores range from 40-160, with lower scores indicating worse cognitive function. Scores one SD below the mean of 100 are indicative of mild cognitive impairment or the lower end of normal cognitive function, scores two SDs below the mean suggest moderate cognitive impairment, and scores three SD below the mean suggest severe cognitive impairment.
Time frame: 2 weeks
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