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NCT04559529 · ClinicalTrials.gov registry record · Phase 2
Pharmacological Modulation of Hippocampal Activity in Psychosis 2
A Phase 2 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
NCT04559529: Completed Phase 2 study, sponsored by Vanderbilt University Medical Center.
NCT04559529 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04559529, a Phase 2 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
Study 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.
Primary Outcome
ASL signal after LEV, using Magnetic Resonance Imaging (MRI) scanning of the brain. ASL measures cerebral blood flow, which is linked to neuronal metabolism and functions as a proxy for neuronal activity.
Interventions
- DRUG Placebo
- DRUG Levetiracetam (LEV) 500 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2020-09-23 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 2 |
What the finished NCT04559529 record still lists
NCT04559529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04559529 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04559529 about?
NCT04559529 is a clinical study titled "Pharmacological Modulation of Hippocampal Activity in Psychosis 2". 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 reson...
What is the current status of trial NCT04559529?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2020-09-23. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT04559529?
The interventions under investigation include: Placebo (DRUG), Levetiracetam (LEV) 500 mg (DRUG).
Who is sponsoring clinical trial NCT04559529?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04559529's enrollment target sits among peer trials
62 1016th of 2000 higher than 975 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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