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Pediatric Open-Label Extension Study
NCT01914393 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326
Conditions Studied
Interventions
- DRUG Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Study Locations (20)
Florida
- Sarkis Clinical Trials - Parent — Gainesville
- Clinical Neuroscience Solutions, Inc. — Orlando
- APG Research, LLC — Orlando
- Medical Research Group of Central Florida — Sanford
- University of South Florida — St. Petersburg
- University of South Florida Rothman Center of Neuropychiatry — Tampa
California
- Diligent Clinical Trials, Inc — Downey
- University of California San Francisco Medical Center — San Francisco
- Neuropsychiatric Research Center of Orange County — Santa Ana
Georgia
- Atlanta Center for Medical Research — Atlanta
- Attalla Consultants, LLC — Smyrna
Alabama
- Harmonex Neuroscience Research — Dothan
Kansas
- Psychiatric Associates — Overland Park
Kentucky
- University Of Kentucky — Lexington
Louisiana
- Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 — Lake Charles
Maryland
- Kennedy Krieger Institute — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2018-10-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01914393
The ClinicalTrials.gov registry entry for NCT01914393 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 702 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 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention — of which Lurasidone 20, 40, 60, 80 mg, flexibly dosed 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: NCT01914393 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, 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 NCT01914393 about?
NCT01914393 is a clinical study titled "Pediatric Open-Label Extension Study". This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D105...
What is the current status of trial NCT01914393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2013-09-30. Estimated completion is 2018-10-17.
What conditions does trial NCT01914393 study?
This clinical trial studies the following conditions: Schizophrenia, Autism, Bipolar Depression. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01914393?
The interventions under investigation include: Lurasidone 20, 40, 60, 80 mg, flexibly dosed (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01914393?
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 NCT01914393 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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