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Clinical Trials/NCT04277936
NCT04277936
Terminated
Phase 2

Pharmacologic Modulation of Hippocampal Activity in Psychosis

Vanderbilt University Medical Center1 site in 1 country1 target enrollmentMay 11, 2020

Overview

Phase
Phase 2
Intervention
Levetiracetam 500 mg
Conditions
Schizophrenia; Psychosis
Sponsor
Vanderbilt University Medical Center
Enrollment
1
Locations
1
Primary Endpoint
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

The purpose of this study is to test whether administration of levetiracetam (LEV), a commonly used anti-epileptic that alters neurotransmitter release, can reduce hippocampal hyperactivity. Specifically, we will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood oxygen level dependence (BOLD) contrast will assess activity with a visual scene processing task that engages the anterior hippocampus and 2) arterial spin labeling (ASL) will assess baseline activity. This study will also assess whether patients have improvement in their symptoms after receiving LEV. Previous studies in people with psychotic disorders have shown that the hippocampus is hyperactive and more activity correlates with worsening of clinical symptoms. Therefore, the aim of this study is to use an intervention to further understand the underlying mechanisms of the hippocampus in psychosis.

Registry
clinicaltrials.gov
Start Date
May 11, 2020
End Date
August 31, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephan Heckers

Department Chair

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Levetiracetam (LEV) 500 mg

Participants will take their first dose of 500 mg LEV. After a two hour time window, the participants will complete MRI study. After MRI, patients will begin a 2-week intervention with 250 mg BID oral LEV.

Intervention: Levetiracetam 500 mg

Outcomes

Primary Outcomes

Hippocampal Activity (Arterial Spin Labeling [ASL] Study)

Time Frame: 2 hours and 2 weeks after administration

Change in ASL signal after drug administration

Hippocampal Recruitment (BOLD Study)

Time Frame: 2 hours and 2 weeks after administration

Change in BOLD signal after drug administration

Secondary Outcomes

  • Positive and Negative Symptoms(2 weeks after administration)
  • Cognitive Symptoms(2 weeks after administration)

Study Sites (1)

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