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Antiepileptic Drug

Low-dose Levetiracetam for Schizophrenia

N/A

Recruiting

Led By Jason Tregellas, Ph.D.

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of schizophrenia or schizoaffective disorder

Normal renal function (as assessed by a metabolic panel at screening if results current within three months are not already available)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

Study Summary

This trial will assess whether the drug levetiracetam can help reduce symptoms of schizophrenia by reducing activity in the hippocampus region of the brain. The investigators also hypothesize that the drug will improve neurocognition in participants with schizophrenia.

Who is the study for?

This trial is for right-handed individuals with schizophrenia or schizoaffective disorder in good health, having normal vital signs and kidney function. It excludes those who are pregnant, have significant neurological issues or head injuries, substance abuse problems, MRI contraindications like claustrophobia or metal implants, and weigh over 450lbs.Check my eligibility

What is being tested?

The study tests if low-dose Levetiracetam (an antiepileptic drug) can reduce hippocampal activity and improve cognition in people with schizophrenia. Participants will be randomly given either the drug or a placebo to compare effects.See study design

What are the potential side effects?

Levetiracetam may cause side effects such as drowsiness, weakness, infection risk increase due to lowered blood cell counts; mood changes including depression; coordination difficulties; gastrointestinal symptoms like nausea; and potential skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia or schizoaffective disorder.

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My kidney function is normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Resting-state neuronal response

Secondary outcome measures

Impaired cognition

Side effects data

From 2006 Phase 4 trial • 251 Patients • NCT00160654

30%

Somnolence

14%

Dizziness

Sedation

Fatigue

Nausea

Headache

Convulsion

Grand mal convulsion

100%

80%

60%

40%

20%

Study treatment Arm

Levetiracetam

Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo, Then LevetiracetamExperimental Treatment2 Interventions

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 II: Levetiracetam, Then PlaceboExperimental Treatment2 Interventions

2 weeks of levetiracetam administration (125 mg pill, bid), followed by a 1-2 week washout, then 2 weeks of placebo pill administration (bid).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Levetiracetam

2017

Completed Phase 4

~3990

Placebo

1995

Completed Phase 3

~2670

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,496 Total Patients Enrolled

9 Trials studying Schizophrenia

311 Patients Enrolled for Schizophrenia

Jason Tregellas, Ph.D.Principal InvestigatorUniversity of Colorado, Denver

2 Previous Clinical Trials

201 Total Patients Enrolled

1 Trials studying Schizophrenia

140 Patients Enrolled for Schizophrenia

Media Library

Levetiracetam (Antiepileptic Drug) Clinical Trial Eligibility Overview. Trial Name: NCT02647437 — N/A

Schizophrenia Research Study Groups: Levetiracetam, Then Placebo, Placebo, Then Levetiracetam

Schizophrenia Clinical Trial 2023: Levetiracetam Highlights & Side Effects. Trial Name: NCT02647437 — N/A

Levetiracetam (Antiepileptic Drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02647437 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic purposes does Levetiracetam typically serve?

"Levetiracetam is a medication most routinely prescribed for juvenile myoclonic epilepsy. Additionally, it has been employed to tackle body weight >20kg complications, epilepsies and myoclonic seizures."

Answered by AI

Could you please elucidate upon other investigations conducted involving Levetiracetam?

"Currently, there are 18 active clinical trials for Levetiracetam. 2 of them have progressed to the third stage of testing, with numerous studies conducted in Brisbane and additional locations across Queensland."

Answered by AI

Does the age restriction for this clinical experiment encompass individuals below 35 years of age?

"Within the scope of this trial's parameters, participants must be at least 18 years old and not exceed 65 years."

Answered by AI

Are there any available slots left in this research endeavor?

"The records on clinicaltrials.gov point to the fact that this study is currently recruiting patients, with its inception date being June 1st 2013 and its most recent update occurring on March 30th 2022."

Answered by AI

What is the anticipated number of participants in this trial?

"Affirmative. According to clinicaltrials.gov, this research project posted on June 1st 2013 is still in search of participants. 30 individuals are needed from one trial site and the details were last updated on March 30th 2022."

Answered by AI

Who meets the qualifications to participate in this research project?

"As of now, 30 adults between the ages 18 and 65 who are diagnosed with Schizophrenia can enrol in this trial. They must be deemed generally healthy before being accepted into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2013. "Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02647437.

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