CompletedNCT00309686
Paliperidone or placebo added to lithium or valproate for mania in bipolarity
About this title
A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder
Read the official source — NCT00309686Medication studyAges 18–65
Understand this study
Who was this study for?
This study was for people with bipolarity. Listed age limits: 18 years to 65 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 dateApril 2006
- Recruitment status
- Completed
- Enrollment listed in the registry
- 300
- 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 18 Years to 65 Years
- Official registry ID
- NCT00309686
- Official title
Show the full official title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood Stabilizers in the Treatment of Acute Manic and Mixed Episodes Associated With Bipolar I Disorder
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Recruitment & locations
CompletedLocations not listed
Questions about this study
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 Paliperidone ER.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.
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