A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

768

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Bipolar Disorder
Interventions
DRUG

Olanzapine

Once daily in dose range of 5 to 20 mg/day for 15 weeks, then until recurrence

DRUG

Paliperidone ER

Once daily in dose range of 3 to 12 mg/day for 15 weeks, then until recurrence

DRUG

Placebo

Once daily until recurrence (only after initial 15 weeks on paliperidone ER)

Trial Locations (78)

Unknown

Scottsdale

Riverside

San Diego

Jacksonville

Honolulu

Chicago

Hoffman Estates

Wichita

New Orleans

Willingboro

Cincinnati

Lyndhurst

Philadelphia

Arlington

Austin

Bellevue

Bulgaria

Radnevo

Sofia

Baoding

Beijing

Guangzhou

Nanjing

Shanghai

Suzhou

Xi'an

San José

Casablanca

Manouba

Berlin

Bochum

Chemnitz

Düsseldorf

Göttingen

Jena

Lübeck

Bangalore

Calicut

Coimbatore

Hyderabad

Ludhiana

Pune

Varanasi

Kuala Lumpur

Panama City

Panama Panama

Gdansk

Krakow

Leszno

Skąpe

Swiecie Poland

Torun

Tuszyn

Bucharest

Craiova

Iași

Tg Mures

Timișoara

Krasnodar

Nizny Novgorod

Perm

Smolensk Region N/A

Yaroslavl

Belgrade

Gornja Toponica

Kragujevac

Novi Kneževac

Cape Town

Durban Kn

Johannesburg

Pretoria

Ankara

Manisa

Dnipro

Donetsk

Kiev

Lviv

Vinnitsa

All Listed Sponsors
lead

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

NCT00490971 - A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder | Biotech Hunter | Biotech Hunter