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NCT02647437 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02647437
Other study ID # 13-1495
Secondary ID UL1TR001082
Status Recruiting
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date June 2024

Study information
Verified date February 2024
Source University of Colorado, Denver
Contact Kristina T Legget, Ph.D.
Phone 303-724-5809
Email kristina.legget@ucdenver.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
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, 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: 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 the body)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Levetiracetam

• Placebo

Locations
Country Name City State
United States University of Colorado Anschutz Medical Campus Aurora Colorado

Sponsors (1)
Lead Sponsor Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Resting-state neuronal response Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest 2 weeks
Secondary Neurocognitive function Cognitive function as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 2 weeks
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