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Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT03034356
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
49
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Actual Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

Drug: Levetiracetam
Anticonvulsant drug
Other Names:
  • Keppra

    • Drug: Placebo
    Placebo
    Experimental: 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).

    Drug: Levetiracetam
    Anticonvulsant drug
    Other Names:
  • Keppra

    • Drug: Placebo
    Placebo

    Outcome Measures

    Primary Outcome Measures

    1. Neurocognitive function [4 weeks]

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

    Secondary Outcome Measures

    1. Resting-state neuronal response [4 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Regional VA Medical Center, Aurora, CO Aurora Colorado United States 80045

    Sponsors and Collaborators

    • VA Office of Research and Development

    Investigators

    • Principal Investigator: Jason R. Tregellas, PhD, Rocky Mountain Regional VA Medical Center, Aurora, CO

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT03034356
    Other Study ID Numbers:
    • MHBB-006-16S
    • I01CX001414
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by VA Office of Research and Development
    Schizophrenia
    Additional relevant MeSH terms:
    Schizophrenia
    Levetiracetam

    Study Results

    No Results Posted as of Jan 6, 2022