Levetiracetam for Schizophrenia

Overseen by Jason R. Tregellas, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study plans to learn more about the effects of levetiracetam (LEV) on brain activity and cognition in schizophrenia and schizoaffective disorder. Levetiracetam is an anti-seizure drug, also called an anticonvulsant.

Research Team

Jason R. Tregellas, PhD

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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.

Inclusion Criteria

Normal vital signs (blood pressure, pulse, respiration)

I have been diagnosed with schizophrenia or schizoaffective disorder.

I am in good health overall.

Exclusion Criteria

Pregnancy

MRI-specific exclusion criteria, e.g.,: claustrophobia, weight>400 lbs, metal in the body

You have recently experienced a serious head injury.

Treatment Details

Interventions

• Levetiracetam (Anticonvulsant)

Trial Overview 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.

Participant Groups

Group I: Placebo, Then Levetiracetam Experimental Treatment 2 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 Placebo Experimental Treatment 2 Interventions

4 weeks of levetiracetam administration (125 mg pill, bid), followed by a 4-week washout, then 4 weeks of placebo pill administration (bid).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine