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Completed Phase 3 Interventional Results available

Lurasidone Pediatric Bipolar Study

ClinicalTrials.gov ID: NCT02046369

Public ClinicalTrials.gov record NCT02046369. 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 Sep 10, 2026, 3:25 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 Randomized, 6-Week, Double-blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study to Evaluate the Efficacy and Safety of Lurasidone in Children and Adolescent Subjects With Bipolar I Depression

Brief summary

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

A study to evaluate efficacy and safety of flexibly dosed Lurasidone in children and adolescents with bipolar I depression

Study identification

NCT ID
NCT02046369
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
350 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
10 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
Feb 28, 2014
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016
Last update posted
Dec 19, 2017

2014 – 2016

United States locations

U.S. sites
30
U.S. states
20
U.S. cities
30
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303
ProScience Research Group Culver City California 90230
Hartford Hospital Hartford Connecticut 06106
Sarkis Clinical Trials - Parent Gainesville Florida 32607
APG Research, LLC Orlando Florida 32803
Atlanta Center for Medical Research Atlanta Georgia 30308
Attalla Consultants, LLC Smyrna Georgia 30080
Capstone Clinical Research, Inc. Libertyville Illinois 60048
Psychiatric Associates Overland Park Kansas 66211
Lake Charles Clinical Trials, LLC Lake Charles Louisiana 70629
Kennedy Krieger Institute Baltimore Maryland 21205
Neurobehavioral Medicine Group, PLLC 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
Bioscience Research, LLC Mount Kisco New York 10549
Finger Lakes Clinical Research Rochester New York 14618
Richmond Behavioral Associates Staten Island New York 10312
University of Cincinnati Medical Center Cincinnati Ohio 45219-0516
University Hospitals Case Medical Center Cleveland Ohio 44106
Cutting Edge Research of Enid Oklahoma City Oklahoma 73116
Research Strategies of Memphis, LLC Memphis Tennessee 38119
BioBehavioral Research of Austin Austin Texas 78759
Pillar Clinical Research, LLC Dallas Texas 75228
Family Psychiatry of The Woodlands, P.A. The Woodlands Texas 77381
Ericksen Research & Development, LLC Clinton Utah 84015
Aspen Clinical Research Orem Utah 84058
University of Virginia Charlottesville Virginia 22903
Clinical Research Partners, LLC Petersburg Virginia 23805
Pacific Institute Of Medical Sciences Bothell Washington 98011

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 36 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02046369, 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, 2017 · Synced Sep 10, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02046369 live on ClinicalTrials.gov.

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