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Completed

NCT Number: NCT02647437

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Left-handedness
  • Pregnancy
  • MRI-specific exclusion criteria (e.g., claustrophobia, weight > 450lbs, metal in the body)

Treatment and study plan

Levetiracetam

Drug

Other names: Keppra

Placebo

Drug

Primary outcomes

  1. Resting-state neuronal response

    Time frame: 2 weeks

    Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest

Secondary outcomes

  1. Neurocognitive function

    Time frame: 2 weeks

    Cognitive function as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2024
Study completion
2024
First posted
Jan 6, 2016
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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