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Anticonvulsant

Levetiracetam for Schizophrenia

Phase 1 & 2
Waitlist Available
Led By Jason R. Tregellas, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of schizophrenia or schizoaffective disorder
Good general health
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will study the effects of LEV on brain activity and cognition in people with schizophrenia or schizoaffective disorder.

Who is the study for?
This trial is for individuals with schizophrenia or schizoaffective disorder who are in good general health and have normal vital signs. It's not suitable for those with substance abuse issues, pregnant women, people who can't undergo MRI (due to claustrophobia, weight over 400 lbs, or metal in the body), or those with significant neurological disorders or head injuries.Check my eligibility
What is being tested?
The study is examining the impact of levetiracetam (LEV), an anti-seizure medication, on brain activity and cognitive function in participants compared to a placebo. The goal is to see if LEV can reduce hippocampal hyperactivity and improve cognition.See study design
What are the potential side effects?
Levetiracetam may cause side effects such as drowsiness, weakness, dizziness, infection risk increase due to immune system changes; mood swings including aggression; coordination difficulties; nausea; and other potential nervous system-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Select...
I am in good health overall.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Neurocognitive function
Secondary outcome measures
Resting-state neuronal response

Side effects data

From 2006 Phase 4 trial • 251 Patients • NCT00160654
30%
Somnolence
14%
Dizziness
6%
Fatigue
6%
Nausea
6%
Headache
6%
Sedation
2%
Convulsion
1%
Grand mal convulsion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Levetiracetam

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, Then LevetiracetamExperimental Treatment2 Interventions
4 weeks of placebo administration (bid), followed by a 4-week washout, then 4 weeks of levetiracetam administration (125 mg pill, bid).
Group II: Levetiracetam, Then PlaceboExperimental Treatment2 Interventions
4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,605 Previous Clinical Trials
3,305,529 Total Patients Enrolled
44 Trials studying Schizophrenia
5,097 Patients Enrolled for Schizophrenia
Jason R. Tregellas, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
1 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Schizophrenia
40 Patients Enrolled for Schizophrenia

Media Library

Levetiracetam (Anticonvulsant) Clinical Trial Eligibility Overview. Trial Name: NCT03034356 — Phase 1 & 2
Schizophrenia Research Study Groups: Placebo, Then Levetiracetam, Levetiracetam, Then Placebo
Schizophrenia Clinical Trial 2023: Levetiracetam Highlights & Side Effects. Trial Name: NCT03034356 — Phase 1 & 2
Levetiracetam (Anticonvulsant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03034356 — Phase 1 & 2

Frequently Asked Questions

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

What additional research has been conducted on the efficacy of Levetiracetam?

"Currently, 18 clinical trials are in progress for Levetiracetam. 2 of these active studies have reached Phase 3 development. While the majority of research is based out of Brisbane, Queensland; a total of 40 sites are running experiments involving this medication."

Answered by AI

Are elderly individuals over the age of seventy-five eligible for this research endeavor?

"This research is open to individuals who are above the age of consent and younger than 65 years old."

Answered by AI

Is there an eligibility criteria for accessing this experimental program?

"This clinical research is searching for 50 people diagnosed with schizophrenia between the ages of 18 and 65 to participate in their trial."

Answered by AI

What conditions is Levetiracetam typically administered to address?

"Levetiracetam is routinely prescribed to treat juvenile myoclonic epilepsy and has been successfully used for other disorders like excessive body weight, epilepsies, and myoclonic seizures."

Answered by AI

How extensive is the participant intake for this research study?

"That is correct, the trial is indeed seeking out participants. As per information available on clinicaltrials.gov, this study was initiated in September 2018 and last updated October 6th 2022; with a target of 50 individuals at one medical centre."

Answered by AI

Is the intake of participants ongoing for this experiment?

"As per clinicaltrials.gov, this experiment is still actively recruiting participants. It was originally posted on September 1st 2018 and modified most recently on October 6th 2022."

Answered by AI
~3 spots leftby Jun 2024