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

Sponsor
University of Colorado, Denver (Other)
Overall Status
Recruiting
CT.gov ID
NCT02647437
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
126
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Patients With Schizophrenia
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Levetiracetam, Then Placebo

2 weeks of levetiracetam administration (125 mg pill, bid), followed by a 1-2 week washout, then 2 weeks of placebo pill administration (bid).

Drug: Levetiracetam
Other Names:
  • Keppra

    • Drug: Placebo
    Experimental: Placebo, Then Levetiracetam

    2 weeks of placebo pill administration (bid), followed by a 1-2 week washout, then 2 weeks of levetiracetam administration (125 mg pill, bid).

    Drug: Levetiracetam
    Other Names:
  • Keppra

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Resting-state neuronal response [2 weeks]

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

    Secondary Outcome Measures

    1. Neurocognitive function [2 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver

    Investigators

    • Principal Investigator: Jason Tregellas, Ph.D., University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02647437
    Other Study ID Numbers:
    • 13-1495
    • UL1TR001082
    First Posted:
    Jan 6, 2016
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Schizophrenia
    Levetiracetam

    Study Results

    No Results Posted as of Apr 1, 2022