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Trial record 22 of 235 for:    levetiracetam

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

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ClinicalTrials.gov Identifier: NCT02647437
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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
Schizophrenia Drug: Levetiracetam Drug: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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 Name: Keppra

Drug: Placebo



Primary Outcome Measures :
  1. Resting-state neuronal response [ Time Frame: 2 weeks ]
    Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest


Secondary Outcome Measures :
  1. Neurocognitive function [ Time Frame: 2 weeks ]
    Cognitive function as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

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): NCT02647437


Contacts
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Contact: Kristina T Legget, Ph.D. 303-724-5809 kristina.legget@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristina T Legget, Ph.D.    303-724-5809    kristina.legget@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Jason Tregellas, Ph.D. University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02647437     History of Changes
Other Study ID Numbers: 13-1495
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Levetiracetam
Anticonvulsants
Nootropic Agents