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NCT03129360 · ClinicalTrials.gov registry record · Phase 2
Levetiracetam in Early Psychosis
A Phase 2 study of Schizophrenia and Psychosis, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03129360 is a Phase 2 study of Schizophrenia and Psychosis that has completed, run by NYU Langone Health. The registered enrollment target is 48 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03129360, a Phase 2 study of Schizophrenia and Psychosis, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
In order to establish target engagement and identify an effective dose the investigators will conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500 mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by pulsed arterial spin labelling (ASL) pre-dose and 2 hours post-dose. The lower dose is calculated to achieve blood levels within the range that were associated with reduced hippocampal activity and improved cognition in patients with mild cognitive impairment; the higher dose is a typical antiepileptic dose. Successful demonstration of target engagement will be defined by an effect size of 0.5 or greater compared to placebo in reduction by levetiracetam of hippocampal blood flow measured by ASL. The optimal dose will be defined by maximal reduction of hippocampal perfusion in the absence of clinically-significant adverse effects. The investigators will also study 8 healthy control subjects to verify that baseline hippocampal blood flow is elevated in the sample of EP subjects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Levetiracetam
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-08-18 |
| Est. Completion | 2021-11-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03129360
The ClinicalTrials.gov registry entry for NCT03129360 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (78% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03129360 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03129360 about?
NCT03129360 is a clinical study titled "Levetiracetam in Early Psychosis". In order to establish target engagement and identify an effective dose the investigators will conduct a placebo-controlled single-dose parallel group trial of levetiracetam 185 mg and 500 mg in 24 medication-naïve early psychosis (EP) patients, measuring hippocampal activity by pulsed arterial spin ...
What is the current status of trial NCT03129360?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2017-08-18. Estimated completion is 2021-11-03.
What conditions does trial NCT03129360 study?
This clinical trial studies the following conditions: Schizophrenia, Psychosis, Schizo Affective Disorder, Schizophreniform.
What interventions are being tested in trial NCT03129360?
The interventions under investigation include: Placebo (DRUG), Levetiracetam (DRUG).
Who is sponsoring clinical trial NCT03129360?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03129360 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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