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NCT04959032 · ClinicalTrials.gov registry record · Phase 3
Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
A Phase 3 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
NCT04959032: Completed Phase 3 study, sponsored by Intra-Cellular Therapies.
NCT04959032 is a Phase 3 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 228 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04959032, a Phase 3 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
Interventions
- DRUG Placebo
- DRUG Lumateperone 42 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2021-07-08 |
| Est. Completion | 2024-08-07 |
| Phase | Phase 3 |
What the finished NCT04959032 record still lists
NCT04959032 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04959032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04959032 about?
NCT04959032 is a clinical study titled "Lumateperone for the Prevention of Relapse in Patients With Schizophrenia". This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).
What is the current status of trial NCT04959032?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2021-07-08. Estimated completion is 2024-08-07.
What interventions are being tested in trial NCT04959032?
The interventions under investigation include: Placebo (DRUG), Lumateperone 42 mg (DRUG).
Who is sponsoring clinical trial NCT04959032?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04959032's enrollment target sits among peer trials
228 1309th of 2000 higher than 691 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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