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OpenTrials
Completed

NCT Number: NCT03034356

Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.

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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

Phase 1 / Phase 2

Primary location

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

About this study

Cognitive symptoms are not currently well-managed in Veterans with schizophrenia, leading to substantially diminished quality of life. Improved treatment strategies clearly are needed. Recent studies suggest taht an overactive hippocampus is associated with cognitive deficits in the illness. Based on findings that the anti-epileptic drug levetiracetam (LEV) reduces hippocampal activity and improves cognition in other clinical populations while being safe and well-tolerated, this study will examine the effects of the drug on hippocampal activity and cognition in Veterans with schizophrenia. In this crossover design, participants will take LEV for 4 weeks and placebo pills for 4 weeks, but will not know the order in which they are taking them.

Who can participate

Healthy volunteers accepted: Yes

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, respiration)

Exclusion criteria

  • Substance abuse
  • Significant neurological disorders
  • Significant head trauma/injury
  • Pregnancy
  • MRI-specific exclusion criteria, e.g.,:
  • claustrophobia
  • weight>400 lbs
  • metal in the body

Treatment and study plan

Levetiracetam

Drug

Anticonvulsant drug

Other names: Keppra

Placebo

Drug

Placebo

Primary outcomes

  1. Neurocognitive Function

    Time frame: Baseline and change from baseline to 4 weeks for each intervention

    Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS; total score). Scores are scaled with a mean of 100 and standard deviation of 15 (higher scores indicating better outcome).

Secondary outcomes

  1. Resting-state Neuronal Response

    Time frame: Baseline and change from baseline to 4 weeks for each intervention

    Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest (fractional amplitude of low frequency fluctuations, fALFF).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2017
Registry last updated
Aug 11, 2026

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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