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Pediatric Schizophrenia Efficacy and Safety Study
NCT01911429 · View on ClinicalTrials.gov ↗
Study Summary
Efficacy and Safety study of Lurasidone in pediatric patients.
Conditions Studied
Interventions
- DRUG Lurasidone 40 mg
- DRUG Lurasidone 80 mg
- DRUG Placebo 40 or 80 mg
Study Locations (20)
California
- California Pharmaceutical Research Institute, Inc — Anaheim
- Central Valley Medical Research — Bakersfield
- ProScience Research Group — Culver City
- Diligent Clinical Trials, Inc — Downey
- Collaborative Neuroscience Network, LLC — Garden Grove
- Global Clinical Trials, LLC — Irvine
- Neuropsychiatric Research Center of Orange County — Orange
- Asclepes Research — Panorama City
- CITrials, Inc. - Riverside & San Bernardino County — Riverside
Florida
- Florida Clinical Research Center, LLC — Bradenton
- Sarkis Clinical Trials - Parent — Gainesville
- APG Research, LLC — Orlando
- Medical Research Group of Central Florida — Sanford
Georgia
- Atlanta Center for Medical Research — Atlanta
- Institute for Behavioral Medicine, LLC — Smyrna
Alabama
- Harmonex Neuroscience Research — Dothan
Connecticut
- Hartford Hospital — Hartford
District of Columbia
- Children's National Medical Center — Washington D.C.
Illinois
- Baber Research Group — Naperville
Louisiana
- Lake Charles Clinical Trials, LLC — Lake Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01911429
The ClinicalTrials.gov registry entry for NCT01911429 describes a study currently listed as completed. 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 327 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sumitomo Pharma America, which has 65 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions — of which Lurasidone 40 mg 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: NCT01911429 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Georgia. 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 NCT01911429 about?
NCT01911429 is a clinical study titled "Pediatric Schizophrenia Efficacy and Safety Study". Efficacy and Safety study of Lurasidone in pediatric patients.
What is the current status of trial NCT01911429?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 327 participants. The study started on 2013-08. Estimated completion is 2015-12.
What conditions does trial NCT01911429 study?
This clinical trial studies the following conditions: Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01911429?
The interventions under investigation include: Lurasidone 40 mg (DRUG), Lurasidone 80 mg (DRUG), Placebo 40 or 80 mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01911429?
This trial is sponsored by Sumitomo Pharma America, which has 65 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01911429 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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