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CompletedNCT02046369

Lurasidone for Depression in Children and Teens Living With Bipolarity

About this titleRead the official source — NCT02046369

Researchers compared Lurasidone and placebo, tracking side effects to assess safety in children with bipolarity type I during a depressive episode.

Medication studyAges 10–17Multiple countries
The study in practice

Understand this study

What did researchers investigate?

Researchers compared Lurasidone and placebo, tracking side effects to assess safety in children with bipolarity type I during a depressive episode.

Who was this study for?

This study was for people with type I bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria applied.

Listed locations
Dothan and 65 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.

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Study clarity

Study information

Study start dateMarch 2014
Recruitment status
Completed
Enrollment listed in the registry
350
Sponsor
Sumitomo Pharma America, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, France, Bulgaria, ...
Age range
From 10 Years to 17 Years
Official registry ID
NCT02046369
Official title
Show the full 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

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Recruitment & locations

Completed

Dothan, United States · Culver City, United States · Hartford, United States

60 more locations
  • Gainesville, United States
  • Orlando, United States
  • Atlanta, United States
  • Smyrna, United States
  • Libertyville, United States
  • Overland Park, United States
  • Lake Charles, United States
  • Baltimore, United States
  • Bloomfield Hills, United States
  • Saint Charles, United States
  • Neptune City, United States
  • Glen Oaks, United States
  • Mount Kisco, United States
  • Rochester, United States
  • Staten Island, United States
  • Cincinnati, United States
  • Cleveland, United States
  • Oklahoma City, United States
  • Memphis, United States
  • Austin, United States
  • Dallas, United States
  • The Woodlands, United States
  • Clinton, United States
  • Orem, United States
  • Charlottesville, United States
  • Petersburg, United States
  • Bothell, United States
  • Rousse, Bulgaria
  • Targovishte, Bulgaria
  • Varna, Bulgaria
  • Barranquilla, Colombia
  • Bogotá, Colombia
  • Nice, France
  • Nantes, France
  • Budapest, Hungary
  • Gyula, Hungary
  • Monterrey, Mexico
  • Culiacán, Mexico
  • Durango, Mexico
  • San Luis Potosí City, Mexico
  • Iloilo City, Philippines
  • Mandaluyong, Philippines
  • Quezon City, Philippines
  • Kobierzyce, Poland
  • Torun, Poland
  • Warsaw, Poland
  • San Juan, Puerto Rico
  • Jeonju, South Korea
  • Gwangju, South Korea
  • Incheon, South Korea
  • Seongnam-si, South Korea
  • Seoul, South Korea
  • Ivano-Frankivsk, Ukraine
  • Kharkiv, Ukraine
  • Kherson, Ukraine
  • Lviv, Ukraine
  • Odesa, Ukraine
  • Poltava, Ukraine
  • Ternopil, Ukraine
  • Vinnytsia, Ukraine
FAQ

Questions about this study

What did researchers investigate?

Researchers compared Lurasidone and placebo, tracking side effects to assess safety in children with bipolarity type I during a depressive episode.

Who is behind this study?

The study sponsor is Sumitomo Pharma America, Inc., a pharmaceutical company.

Did this study involve medication?

Yes. The study involved medication, including Lurasidone and Placebo.

Who was this study for?

This study was for people with type I bipolarity. Listed age limits: 10 years to 17 years. Other eligibility criteria applied.

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