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

NCT ID: NCT02647437

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Placebo

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Levetiracetam

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Keppra

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Tregellas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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13-1495

Identifier Type: -

Identifier Source: org_study_id

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