Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable schizophrenia
Started Jun 2013
Longer than P75 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 29, 2015
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedApril 22, 2025
April 1, 2025
11.3 years
December 29, 2015
April 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Resting-state neuronal response
Neuronal response (measured via functional magnetic resonance imaging, fMRI) in the hippocampus during rest
2 weeks
Secondary Outcomes (1)
Neurocognitive function
2 weeks
Study Arms (2)
Levetiracetam, Then Placebo
EXPERIMENTAL2 weeks of levetiracetam administration (125 mg pill, bid), followed by a 1-2 week washout, then 2 weeks of placebo pill administration (bid).
Placebo, Then Levetiracetam
EXPERIMENTAL2 weeks of placebo pill administration (bid), followed by a 1-2 week washout, then 2 weeks of levetiracetam administration (125 mg pill, bid).
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Substance abuse
- Significant neurological disorders
- Significant head trauma/injury
- Left-handedness
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Tregellas, Ph.D.
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2015
First Posted
January 6, 2016
Study Start
June 1, 2013
Primary Completion
September 1, 2024
Study Completion
September 1, 2024
Last Updated
April 22, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share