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 : April 1, 2022
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Levetiracetam Drug: Placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 2023|
|Estimated Study Completion Date :||December 2023|
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).
Other Name: Keppra
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).
Other Name: Keppra
- Resting-state neuronal response [ Time Frame: 2 weeks ]Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest
- Neurocognitive function [ Time Frame: 2 weeks ]Cognitive function as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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
|Contact: Kristina T Legget, Ph.D.||firstname.lastname@example.org|
|United States, Colorado|
|University of Colorado Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Kristina T Legget, Ph.D. 303-724-5809 email@example.com|
|Principal Investigator:||Jason Tregellas, Ph.D.||University of Colorado, Denver|