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Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03034356
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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
Schizophrenia Drug: Levetiracetam Drug: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2018
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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 Name: 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 Name: Keppra

Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Neurocognitive function [ Time Frame: 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 [ Time Frame: 4 weeks ]
    Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03034356


Contacts
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Contact: Jason R Tregellas, PhD (303) 315-1086 Jason.Tregellas@va.gov

Locations
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United States, Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO Recruiting
Aurora, Colorado, United States, 80045
Contact: Jason R Tregellas, PhD    303-315-1086    Jason.Tregellas@va.gov   
Principal Investigator: Jason R. Tregellas, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jason R. Tregellas, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03034356     History of Changes
Other Study ID Numbers: MHBB-006-16S
I01CX001414 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified, anonymized dataset will be created and shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
 Levetiracetam
Anticonvulsants
Nootropic Agents