Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06229210 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
A Phase 3 study of Schizophrenia and Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06229210: Recruiting Phase 3 study of Schizophrenia and Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
NCT06229210 is a Phase 3 study of Schizophrenia and Autism Spectrum Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 500 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06229210, a Phase 3 study of Schizophrenia and Autism Spectrum Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Primary Outcome
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Conditions Studied
Interventions
- DRUG Lumateperone
Study Locations (20)
Florida
- Clinical Site - Gainesville
- Clinical Site - Hialeah
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami Gardens
California
- Clinical Site - Anaheim
- Clinical Site - Colton
- Clinical Site - Garden Grove
- Clinical Site - Long Beach
- Clinical Site - Redlands
- Clinical Site - San Diego
- Clinical Site - West Covina
Arizona
- Clinical Site - Phoenix
Arkansas
- Clinical Site - Little Rock
Colorado
- Clinical Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-01-25 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
What NCT06229210 shows while recruiting
NCT06229210 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (130% higher).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Lumateperone is the first listed.
NCT06229210 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06229210 about?
NCT06229210 is a clinical study titled "Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder". This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
What is the current status of trial NCT06229210?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-01-25. Estimated completion is 2027-12.
What conditions does trial NCT06229210 study?
This clinical trial studies the following conditions: Schizophrenia, Autism Spectrum Disorder, Bipolar Disorder.
What interventions are being tested in trial NCT06229210?
The interventions under investigation include: Lumateperone (DRUG).
Who is sponsoring clinical trial NCT06229210?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06229210 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
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 NCT06229210's enrollment target sits among peer trials
500 39th of 315 higher than 277 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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
-
NBI-1117568-SCZ3032: Long-Term Evaluation of NBI-1117568 in Adults With Schizophrenia
RECRUITING · Phase 3
-
NBI-1117568-SCZ3030: Evaluation of NBI-1117568 in Inpatient Adults With Schizophrenia
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)
RECRUITING · Phase 3
-
Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With Schizophrenia
RECRUITING · Phase 3
-
Safety and Efficacy of Brilaroxazine (RP5063) in Schizophrenia
RECRUITING · Phase 3
-
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00001230 · 500 participants
Host Response to Infection and Treatment in Filarial Diseases
- NCT00001529 · 500 participants
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
- NCT00697411 · 500 participants
Study of Selected X-Linked Disorders: Aicardi Syndrome
- NCT00903110 · 500 participants
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI