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

Last updated: April 21, 2025
Sponsor: University of Colorado, Denver
Overall Status: Completed

Phase

N/A

Condition

Mood Disorders

Tourette's Syndrome

Psychosis

Treatment

Levetiracetam

Placebo

Clinical Study ID

NCT02647437
13-1495
UL1TR001082
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 resultscurrent within three months are not already available)

Exclusion

Exclusion Criteria:

  1. Substance abuse

  2. Significant neurological disorders

  3. Significant head trauma/injury

  4. Left-handedness

  5. Pregnancy

  6. MRI-specific exclusion criteria (e.g., claustrophobia, weight > 450lbs, metal in thebody)

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Levetiracetam
Phase:
Study Start date:
June 01, 2013
Estimated Completion Date:
September 30, 2024

Study Description

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.

Connect with a study center

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

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