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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 Oct 27, 2026, 1:19 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
Mar 2014 (Type not available)
Primary completion
Oct 2016 (Actual)
Completion
Oct 2016 (Actual)
Last update posted
Dec 20, 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 20, 2017 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02046369 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →