NCT04559529

Pharmacological Modulation of Hippocampal Activity in Psychosis 2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 in people with psychotic disorders. Specifically, the investigators will utilize two functional magnetic resonance imaging (MRI) techniques: 1) blood-oxygen-level-dependent (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. 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.

Conditions

• Schizophrenia; Psychosis

Interventions

Type	Name	Description
DRUG	Levetiracetam (LEV) 500 mg	The levetiracetam pill will look just like the placebo pill.
DRUG	Placebo	The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-09-23
• Last updated: 2024-02-05
• Results posted: 2024-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study