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NCT06372964 · ClinicalTrials.gov registry record · Phase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
A Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 384
- Enrollment target
- 20
- Study locations
NCT06372964 is a Phase 3 study of Bipolar Depression that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 384 participants, above the 203-participant average among 29 other Bipolar Depression trials with a reported enrollment target (89% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT06372964, a Phase 3 study of Bipolar Depression, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 384 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone
Study Locations (20)
Florida
- Clinical Site - Gainesville
- Clinical Site - Hialeah
- Clinical Site - Homestead
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
California
- Clinical Site - Anaheim
- Clinical Site - Redlands
- Clinical Site - Sacramento
- Clinical Site - San Diego
- Clinical Site - West Covina
Alabama
- Clinical Site - Dothan
Arkansas
- Clinical Site - Little Rock
Colorado
- Clinical Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 384 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2027-05 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06372964
The ClinicalTrials.gov registry entry for NCT06372964 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 384 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 203-participant average among 29 other Bipolar Depression trials with a reported enrollment target (89% higher). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06372964 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT06372964 about?
NCT06372964 is a clinical study titled "Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients". This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for ...
What is the current status of trial NCT06372964?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 384 participants. The study started on 2024-05-13. Estimated completion is 2027-05.
What conditions does trial NCT06372964 study?
This clinical trial studies the following conditions: Bipolar Depression.
What interventions are being tested in trial NCT06372964?
The interventions under investigation include: Placebo (DRUG), Lumateperone (DRUG).
Who is sponsoring clinical trial NCT06372964?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06372964 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.