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NCT04317807 · ClinicalTrials.gov registry record · Phase 2

R33: Levetiracetam in Early Psychosis

A Phase 2 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target

NCT04317807 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 65 participants.

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The verdict

NCT04317807, a Phase 2 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target

Study Summary

This is a 12-week study of levetiracetam added to a second generation antipsychotic in early psychosis patients who have been ill for less than 5 years and continue to experience psychotic symptoms despite at least 8 weeks of antipsychotic treatment. Levetiracetam (Keppra) is a medication approved for the treatment of epilepsy; it reduces excessive activity in the brain. This study will test the hypotheses that adding levetiracetam will improve psychotic symptoms that are unresponsive to antipsychotic treatment and will protect the brain from atrophy (volume loss). .

Interventions

  • OTHER Placebo
  • DRUG Levetiracetam Pill

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2020-08-27
Est. Completion 2025-04-10
Phase Phase 2

Sponsor

NYU Langone Health

1,164 total trials

What the Registry Record Tells You About NCT04317807

The ClinicalTrials.gov registry entry for NCT04317807 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04317807 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04317807 about?

NCT04317807 is a clinical study titled "R33: Levetiracetam in Early Psychosis". This is a 12-week study of levetiracetam added to a second generation antipsychotic in early psychosis patients who have been ill for less than 5 years and continue to experience psychotic symptoms despite at least 8 weeks of antipsychotic treatment. Levetiracetam (Keppra) is a medication approved f...

What is the current status of trial NCT04317807?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2020-08-27. Estimated completion is 2025-04-10.

What interventions are being tested in trial NCT04317807?

The interventions under investigation include: Placebo (OTHER), Levetiracetam Pill (DRUG).

Who is sponsoring clinical trial NCT04317807?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.