A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of Risperidone Long-Acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar I Disorder, with Open-Label Extensio
- Conditions
- BIPOLAR MANIA
- Registration Number
- EUCTR2004-003781-14-ES
- Lead Sponsor
- Johnson and Johnson Pharmaceutical Research and Development, una división de Janssen-Cilag, S.A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Male or female between theages of 18-65
Diagnosis of bipoar I disorder as defined by DSM-IV-TR
Currently experienceing a manic or mixed episode or stable
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
History of more that 4 mood episodes each year (rapid cycling)
Meets DSM-IV-TR criteria for depressive episode, antisocial or borderline personality disorder
Has an unstable serious medical ilness
Known or suspected history of substance abuse withing helast 6 months
Significant risk of injuring him/herself or others or causing significant damage to property
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method