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NCT03034356 Clinical Trial

Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

Schizophrenia Clinical Trial

Official title:
Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03034356
Other study ID # MHBB-006-16S
Secondary ID I01CX001414
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 1, 2018
Est. completion date June 30, 2024

Study information
Verified date October 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 67
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Levetiracetam
Anticonvulsant drug
• Placebo
Placebo

Locations
Country Name City State
United States Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Neurocognitive function Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS) 4 weeks
Secondary Resting-state neuronal response Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest. 4 weeks
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