Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- Levetiracetam
- Conditions
- Schizophrenia
- Sponsor
- VA Office of Research and Development
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Neurocognitive Function
- Status
- Completed
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Levetiracetam, Then Placebo
4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid).
Intervention: Levetiracetam
Levetiracetam, Then Placebo
4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid).
Intervention: Placebo
Placebo, Then Levetiracetam
4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid).
Intervention: Levetiracetam
Placebo, Then Levetiracetam
4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid).
Intervention: Placebo
Outcomes
Primary Outcomes
Neurocognitive Function
Time Frame: 4 weeks
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
- Resting-state Neuronal Response(4 weeks)