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Lurasidone Pediatric Bipolar Study

NCT02046369 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2017-12-20

Study results available
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Summary

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

Conditions

  • Bipolar I Depression

Interventions

DRUG

Lurasidone

Lurasidone flexibly dosed 20-80 mg once daily

DRUG

Placebo

Placebo Comparator once daily

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • United States
  • Bulgaria
  • Colombia
  • France
  • Hungary
  • Mexico
  • Philippines
  • Poland
  • Puerto Rico
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02046369 on ClinicalTrials.gov