Reducing Hippocampal Hyperactivity and Improving Cognition in Schizophrenia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02647437

Schizophrenia

COMPLETED NA

Pharmacologic Modulation of Hippocampal Activity in Psychosis

NCT04277936

Schizophrenia; Psychosis

TERMINATED PHASE2

Levetiracetam in Early Psychosis

NCT03129360

Psychosis Schizophrenia Schizo Affective Disorder +1 more

COMPLETED PHASE2

Nicotinic Enhancement of Cognitive Remediation Training in Schizophrenia

NCT02069392

Schizophrenia Schizoaffective Disorder

COMPLETED NA

Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia

NCT02237235

Schizophrenia Schizoaffective Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cognitive symptoms are not currently well-managed in Veterans with schizophrenia, leading to substantially diminished quality of life. Improved treatment strategies clearly are needed. Recent studies suggest taht an overactive hippocampus is associated with cognitive deficits in the illness. Based on findings that the anti-epileptic drug levetiracetam (LEV) reduces hippocampal activity and improves cognition in other clinical populations while being safe and well-tolerated, this study will examine the effects of the drug on hippocampal activity and cognition in Veterans with schizophrenia. In this crossover design, participants will take LEV for 4 weeks and placebo pills for 4 weeks, but will not know the order in which they are taking them.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Levetiracetam, Then Placebo

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

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Anticonvulsant drug

Placebo

Intervention Type DRUG

Placebo

Placebo, Then Levetiracetam

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

Group Type EXPERIMENTAL

Levetiracetam

Intervention Type DRUG

Anticonvulsant drug

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Levetiracetam

Anticonvulsant drug

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Keppra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of schizophrenia or schizoaffective disorder
* Good general health
* Normal vital signs (blood pressure, pulse, respiration)

Exclusion Criteria

* Substance abuse
* Significant neurological disorders
* Significant head trauma/injury
* Pregnancy

* claustrophobia
* weight\>400 lbs
* metal in the body

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes