Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

NCT06229210 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 500 participants
Start Date 2024-01-25
Est. Completion 2027-12
Phase Phase 3

Sponsor

Intra-Cellular Therapies

54 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06229210

The ClinicalTrials.gov registry entry for NCT06229210 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 54 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06229210 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06229210?

The interventions under investigation include: Lumateperone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06229210?

This trial is sponsored by Intra-Cellular Therapies, which has 54 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial