← Back to Search

Anti-epileptic

Levetiracetam for Psychosis

Phase 2
Waitlist Available
Led By Stephan Heckers, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours after placebo administration
Awards & highlights

Study Summary

This trial will test whether the anti-epileptic drug levetiracetam can reduce hippocampal hyperactivity in people with psychotic disorders, in order to better understand the role of the hippocampus in psychosis.

Who is the study for?
This trial is for English-speaking adults aged 18-65 with a confirmed diagnosis of a psychotic disorder, such as schizophrenia. Participants must be physically healthy, have a stable medication regimen for at least two weeks, and not be pregnant or nursing. Women should use effective contraception during the study.Check my eligibility
What is being tested?
The study tests if levetiracetam (LEV), an anti-epileptic drug, can reduce overactivity in the hippocampus of people with psychosis using MRI techniques. The goal is to understand how this brain region contributes to their symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, LEV may generally cause dizziness, fatigue, coordination problems among others. Side effects from placebos are usually psychological due to expectations rather than the substance itself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours after placebo administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours after placebo administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Levetiracetam (LEV)
Hippocampal Activity (Arterial Spin Labeling [ASL] Study) After Placebo
Hippocampal Recruitment (Blood-Oxygen-Level-Dependent [BOLD] Study) After Levetiracetam (LEV)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Placebo, then Levetiracetam (LEV)Experimental Treatment2 Interventions
Participants will first receive two placebo capsules on the same day. After one week, they will receive two 250mg LEV capsules on the same day.
Group II: Levetiracetam (LEV), then PlaceboExperimental Treatment2 Interventions
Participants will first receive two 250mg LEV capsules on the same day. After one week, they will receive two placebo capsules on the same day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Levetiracetam (LEV) 500 mg
2020
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,130 Total Patients Enrolled
4 Trials studying Schizophrenia
107 Patients Enrolled for Schizophrenia
Stephan Heckers, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt Psychiatric Hospital
University Zu Koln (Medical School)
Mass Gen Hospital (Residency)

Media Library

Levetiracetam (Anti-epileptic) Clinical Trial Eligibility Overview. Trial Name: NCT04559529 — Phase 2
Schizophrenia Research Study Groups: Levetiracetam (LEV), then Placebo, Placebo, then Levetiracetam (LEV)
Schizophrenia Clinical Trial 2023: Levetiracetam Highlights & Side Effects. Trial Name: NCT04559529 — Phase 2
Levetiracetam (Anti-epileptic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04559529 — Phase 2

Frequently Asked Questions

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

What potential hazards are associated with a dosage of Levetiracetam (LEV) 500 mg?

"Our team at Power evaluated the safety of Levetiracetam (LEV) 500mg and gave it a score of 2 due to there being some data that corroborates its security, although none which prove efficacy."

Answered by AI

Could I potentially take part in this investigation?

"Currently, the research team is looking for 60 individuals aged 18 - 65 who have been diagnosed with a mental illness. Furthermore, they must be physically healthy (as determined by BMI and medical history) as well as meet specific criteria related to their psychosis."

Answered by AI

Are there still opportunities for volunteers to participate in this experiment?

"Per the records on clinicaltrials.gov, this research is actively recruiting participants. Inaugurated on September 23rd 2020 and most recently edited in March 15th 2022, this trial requires further enrollment of patients."

Answered by AI

What is the maximum capacity for enrolment in this research project?

"Affirmative. According to the information on clinicaltrials.gov, this clinical trial is in process of seeking out relevant subjects; it was initially posted on September 23rd 2020 and last updated March 15th 2022. A total of 60 participants are sought at a single medical centre."

Answered by AI

To what ailment is the drug Levetiracetam (LEV) 500 mg generally prescribed?

"LEV 500 mg is often prescribed to treat juvenile myoclonic epilepsy, as well as a variety of other symptoms such as bodyweight >20 kg, epilepsies and myoclonic seizures."

Answered by AI

Is enrollment available for elderly individuals in this experiment?

"This trial is available for individuals aged 18 to 65. For younger and older patients, there are 144 trials specifically designed for those under the age of consent and 377 options tailored towards elderly participants respectively."

Answered by AI

Are there documented accounts of trials utilizing Levetiracetam (LEV) 500 mg?

"Presently, 18 clinical trials exploring Levetiracetam (LEV) 500 mg are currently underway. Of these explorations, two have reached Phase 3 status - and there are 40 different sites situated around the world conducting studies related to this medication. Notably, Brisbane Queensland has numerous locations hosting such study groups."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacological Modulation of Hippocampal Activity in Psychosis 2
Stephan Heckers 2020. "Pharmacological Modulation of Hippocampal Activity in Psychosis 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04559529.
~14 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top