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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: Completed Phase 2 study, sponsored by NYU Langone Health.
NCT04317807 is a Phase 2 study that has completed, run by NYU Langone Health. The registered enrollment target is 65 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower). According to ClinicalTrials.gov, the official US trial registry.
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). .
Primary Outcome
The efficacy of levetiracetam 500 mg bid vs. placebo on symptoms will be measured by the BPRS total score. Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that measures positive symptoms, negative symptoms, general psychopathology and affective symptoms. Individual items are scored on a seven point likert scale. The total score is the sum of responses and ranges from 18 to 126; a higher score on the BPRS items indicates increased severity of symptoms.
Interventions
- OTHER Placebo
- DRUG Levetiracetam Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-08-27 |
| Est. Completion | 2025-04-10 |
| Phase | Phase 2 |
What the finished NCT04317807 record still lists
NCT04317807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (51% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04317807 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04317807's enrollment target sits among peer trials
65 987th of 2000 higher than 1,005 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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