CompletedNCT00035802
Topiramate for manic or mixed episodes in adolescents with bipolarity
About this title
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
Read the official source — NCT00035802Researchers compared Topiramate and placebo to find out how the approaches affected manic symptoms in young people with bipolarity type I.
Medication studyAges 13–17
Understand this study
What did researchers investigate?
Researchers compared Topiramate and placebo to find out how the approaches affected manic symptoms in young people with bipolarity type I.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 13 years to 17 years. Other eligibility criteria applied.
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study information
Study start dateJanuary 2002
- Recruitment status
- Completed
- Enrollment listed in the registry
- 13
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- 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
- Not clearly listed
- Age range
- From 13 Years to 17 Years
- Official registry ID
- NCT00035802
- Official title
Show the full official title
A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension
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Recruitment & locations
CompletedLocations not listed
Questions about this study
What did researchers investigate?
Researchers compared Topiramate and placebo to find out how the approaches affected manic symptoms in young people with bipolarity type I.
Who is behind this study?
The study sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., a pharmaceutical company.
Did this study involve medication?
Yes. The study involved medication, including Topiramate and Placebo.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 13 years to 17 years. Other eligibility criteria applied.
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