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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

Tracking Information
First Submitted Date  ICMJE January 25, 2017
First Posted Date  ICMJE January 27, 2017
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Neurocognitive function [ Time Frame: 4 weeks ]
Cognitive function as measured by the Repeatable Battery for the Assessment of Neurological Status (RBANS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03034356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2017)
Resting-state neuronal response [ Time Frame: 4 weeks ]
Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
Official Title  ICMJE Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: Levetiracetam
    Anticonvulsant drug
    Other Name: Keppra
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: Levetiracetam
    • Drug: 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).
    Interventions:
    • Drug: Levetiracetam
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2022
Estimated Primary Completion Date September 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jason R Tregellas, PhD (303) 315-1086 Jason.Tregellas@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03034356
Other Study ID Numbers  ICMJE MHBB-006-16S
I01CX001414 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: A de-identified, anonymized dataset will be created and shared.
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason R. Tregellas, PhD Rocky Mountain Regional VA Medical Center, Aurora, CO
PRS Account VA Office of Research and Development
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP