CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
Levetiracetam (LEV) 500 mg +1 moredrug
Likely dose
Levetiracetam (LEV) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04559529
NCT04559529Phase 2Completed

Pharmacological Modulation of Hippocampal Activity in Psychosis 2

Vanderbilt University Medical Center·interventional·Posted Sep 23, 2020·Updated Feb 5, 2024

In Brief

A Phase 2 clinical trial evaluating Levetiracetam (LEV) 500 mg and Placebo for Schizophrenia; Psychosis. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 23, 2020
Enrollment StartSep 23, 2020
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.8 years ago

Interventions

Levetiracetam (LEV) 500 mgdrug

The levetiracetam pill will look just like the placebo pill.

Placebodrug

The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.