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 DEPR...
This historical record does not confirm current site availability.
Understand this study
What is this study about?
This EU register entry describes an interventional medicine trial, designed to assign participants a study treatment. The protocol sets out the treatment, eligibility criteria and assessments. Check the source details below for country statuses and any transfer to CTIS.
Who could participate?
This study is for people with type I bipolarity. Other eligibility criteria apply.
- Listed locations
- Bulgaria · France and 4 more locations
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
What to know before participating
This is historical registry information. What is the current study status and protocol?
Things to check before joining
- Recruitment status
- Recruitment unclear
- Enrollment listed in the registry
- 340
- Sponsor
- SUNOVION PHARMACEUTICALS INC.
- Sponsor type
- Other organization
- 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
- France, United Kingdom, Bulgaria, ...
- Age range
- Not clearly listed
- Official registry ID
- EUCTR 2013-004903-37
- 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 DEPR...
Recruitment & locations
Bulgaria · France · Germany
3 more locations
- Hungary
- Italy
- United Kingdom
Registry details
- Outside EU/EEA — Not reported
- Bulgaria — Completed
- Germany — Ongoing
- France — Ongoing
- United Kingdom — Completed
- Hungary — Completed
- Italy — Not Authorised
Interested in joining this study?
Questions about this study
Who is behind this study?
The study sponsor is SUNOVION PHARMACEUTICALS INC.
Who can participate?
This study is for people with type I bipolarity. Other eligibility criteria apply.
