A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder

PHASE3CompletedINTERVENTIONAL
Enrollment

585

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

April 30, 2009

Conditions
Bipolar Disorder
Interventions
DRUG

Olanzapine

Intramuscular injections of placebo every 2 weeks and oral olanzapine 10 mg daily

DRUG

Placebo

Intramuscular injections of placebo every 2 weeks and oral placebo daily

DRUG

Risperidone Long Acting Injectable (LAI)

Intramuscular injections of risperidone LAI (25, 37.5, or 50 mg) every 2 weeks and oral placebo daily

Trial Locations (63)

Unknown

Baoding

Beijing

Guangzhou

Nanjing

Shanghai

Suozhou

Wuhan

Barranquilla Atlantico

Bello Antioquia

Bogotá

Bogotá S/N

Medellin Antioquia

Pereira Risaralda

Freiburg im Breisgau

Hildesheim

Oranienburg

Athens

Ahmedabad

Bangalore

Chennai

Hyderabad

Ludhiana

Mangalore

Mumbai

New Delhi

Pune

Varanasi

Jakarta

Amman

Beirut

Johor Bahru

Kuala Lumpur

Mexico City

Mérida

Monterrey

Puebla City

Tabasco

Tampico

Zapopan

Lima

Lima Lima

Iloilo City

Mandaluyong

Mandaue City

Arkhangelsky District

Chelyabinsk

Izhevsk

Kazan’

Moscow

Moscow Region

Nizny Novgorod

Orenburg

Saint Petersburg

Saratov

Stavropol Na

Tomsk Na

Voronezh

Bloemfontein

Cape Town

Durban

Pretoria

Tainan City

Taipei

All Listed Sponsors
lead

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

NCT00391222 - A Study to Evaluate the Efficacy and Safety of Risperidone for the Prevention of Mood Episodes in the Treatment of Patients With Bipolar I Disorder | Biotech Hunter | Biotech Hunter