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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: Recruiting Phase 3 study of Bipolar Depression, sponsored by Intra-Cellular Therapies.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113.
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 |
What NCT06372964 shows while recruiting
NCT06372964 is an interventional study that assigns participants to a tested intervention. The registered 384 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 29 other Bipolar Depression trials with a reported enrollment target (89% higher).
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 names 20 study sites across 5 states, led by 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
Similar trials for Bipolar Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06372964's enrollment target sits among peer trials
384 7th of 29 higher than 23 of 29 other Bipolar Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Depression 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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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
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Lumateperone Monotherapy for the Treatment of Bipolar Depression Conducted Globally
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Clinical Trial Evaluating ITI-007 (Lumateperone) as a Monotherapy for the Treatment of Bipolar Depression
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Seroquel in Bipolar Depression Versus SSRI
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