CompletedNCT00490971
A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolarity type I
Researchers compared Paliperidone ER, placebo and Olanzapine to find out how the approaches affected how long people remain free of a new mood episode in people with bipolarity type I.
Medication studyAges 18–65Multiple countries
Understand this study
What did researchers investigate?
Researchers compared Paliperidone ER, placebo and Olanzapine to find out how the approaches affected how long people remain free of a new mood episode in people with bipolarity type I.
Who was this study for?
This study was for people with bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.
- Listed locations
- Scottsdale, United States · Riverside, United States and 78 more locationsSee all locations and recruitment
- Study phase
- Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study information
Study start dateMay 2006
- Recruitment status
- Completed
- Enrollment listed in the registry
- 768
- 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
- United States, France, Bulgaria, ...
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT00490971
- Official title
Show the full official title
A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder
Recruitment & locations
CompletedScottsdale, United States · Riverside, United States · San Diego, United States
77 more locations
- Jacksonville, United States
- Honolulu, United States
- Chicago, United States
- Hoffman Estates, United States
- Wichita, United States
- New Orleans, United States
- Willingboro, United States
- Cincinnati, United States
- Lyndhurst, United States
- Philadelphia, United States
- Arlington, United States
- Austin, United States
- Bellevue, United States
- Bulgaria, Bulgaria
- Radnevo, Bulgaria
- Sofia, Bulgaria
- Baoding, China
- Beijing, China
- Guangzhou, China
- Nanjing, China
- Shanghai, China
- Suzhou, China
- Xi'an, China
- San José, Costa Rica
- Casablanca, France
- Manouba, France
- Berlin, Germany
- Bochum, Germany
- Chemnitz, Germany
- Düsseldorf, Germany
- Göttingen, Germany
- Jena, Germany
- Lübeck, Germany
- Bangalore, India
- Calicut, India
- Coimbatore, India
- Hyderabad, India
- Ludhiana, India
- Pune, India
- Varanasi, India
- Kuala Lumpur, Malaysia
- Panama City, Panama
- Panama Panama, Panama
- Gdansk, Poland
- Krakow, Poland
- Leszno, Poland
- Skąpe, Poland
- Swiecie Poland, Poland
- Torun, Poland
- Tuszyn, Poland
- Bucharest, Romania
- Craiova, Romania
- Iași, Romania
- Tg Mures, Romania
- Timișoara, Romania
- Krasnodar, Russia
- Nizny Novgorod, Russia
- Perm, Russia
- Smolensk Region N/A, Russia
- Yaroslavl, Russia
- Belgrade, Serbia
- Gornja Toponica, Serbia
- Kragujevac, Serbia
- Novi Kneževac, Serbia
- Cape Town, South Africa
- Durban Kn, South Africa
- Johannesburg, South Africa
- Pretoria, South Africa
- Ankara, Türkiye
- Manisa, Türkiye
- Dnipro, Ukraine
- Donetsk, Ukraine
- Kiev, Ukraine
- Lviv, Ukraine
- Vinnitsa, Ukraine
- Russia
- Türkiye
Questions about this study
What did researchers investigate?
Researchers compared Paliperidone ER, placebo and Olanzapine to find out how the approaches affected how long people remain free of a new mood episode in 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 Olanzapine, Paliperidone ER and Placebo.
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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