Pharmacologic Modulation of Hippocampal Activity in Psychosis

Phase 2

Terminated

• Conditions: Schizophrenia; Psychosis
• Interventions: Drug: Levetiracetam 500 mg

• Registration Number: NCT04277936
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Study First Posted: 2020-02-20
• Study Start: 2020-05-11
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Results First Submitted: 2021-06-15
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-14
• Last Update Submitted: 2021-07-14
• Results First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam (LEV) 500 mg	Levetiracetam 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.

Primary Outcome Measures

Name	Time	Method
Hippocampal Activity (Arterial Spin Labeling [ASL] Study)	2 hours and 2 weeks after administration	Change in ASL signal after drug administration
Hippocampal Recruitment (BOLD Study)	2 hours and 2 weeks after administration	Change in BOLD signal after drug administration

Secondary Outcome Measures

Name	Time	Method
Cognitive Symptoms	2 weeks after administration	Change in eye-tracking relational memory task
Positive and Negative Symptoms	2 weeks after administration	Change PANSS score

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States