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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 is a Phase 2 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 62 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04559529
The ClinicalTrials.gov registry entry for NCT04559529 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04559529 reports 0 study locations.
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.
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