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Completed Phase 3 Interventional Results available

Pediatric Open-Label Extension Study

ClinicalTrials.gov ID: NCT01914393

Public ClinicalTrials.gov record NCT01914393. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:58 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01914393
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
702 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2013 (Actual)
Primary completion
Oct 17, 2018 (Actual)
Completion
Oct 17, 2018 (Actual)
Last update posted
Dec 19, 2019

2013 – 2018

United States locations

U.S. sites
35
U.S. states
17
U.S. cities
34
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303 —
Diligent Clinical Trials, Inc Downey California 90241 —
University of California San Francisco Medical Center San Francisco California 94143 —
Neuropsychiatric Research Center of Orange County Santa Ana California 92701 —
Sarkis Clinical Trials - Parent Gainesville Florida 32607 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32801 —
APG Research, LLC Orlando Florida 32803 —
Medical Research Group of Central Florida Sanford Florida 32771 —
University of South Florida St. Petersburg Florida 33701 —
University of South Florida Rothman Center of Neuropychiatry Tampa Florida 33613 —
Atlanta Center for Medical Research Atlanta Georgia 30308 —
Attalla Consultants, LLC Smyrna Georgia 30080 —
Psychiatric Associates Overland Park Kansas 66211 —
University Of Kentucky Lexington Kentucky 40509 —
Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 Lake Charles Louisiana 70601 —
Kennedy Krieger Institute Baltimore Maryland 21205 —
Neurobehavioral medicine Group, LLC Bloomfield Hills Michigan 48302 —
St. Charles Psychiatric Associates Saint Charles Missouri 63301 —
Jersey Shore University Medical Center Neptune City New Jersey 07753 —
North Shore/Long Island Jewish PRIME Glen Oaks New York 11004 —
Dr. Jeanette Cueva Mount Kisco New York 10549 —
Montefiore Medical Center PRIME New York New York 10467 —
Finger Lakes Clinical Research Rochester New York 10618 —
Richmond Behavioral Associates Staten Island New York 10312 —
University of Cincinnati Medical Center Cincinnati Ohio 45219 —
University Hospitals Case Medical Center Cleveland Ohio 44106 —
The Ohio State University Nisonger Center Columbus Ohio 43210 —
Cutting Edge Research Group Oklahoma City Oklahoma 73116 —
Pillar Clinical Research, LLC Dallas Texas 75243 —
Family Psychiatry of The Woodlands, P.A. The Woodlands Texas 77381 —
Ericksen Research & Development, LLC Clinton Utah 84015 —
University of Virginia Charlottesville Virginia 22903 —
Neuroscience, Inc. Herndon Virginia 20170 —
Clinical Research Partners, LLC Petersburg Virginia 23805 —
Carilion Clinic Roanoke Virginia 24014 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01914393, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 19, 2019 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01914393 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →