Status:
COMPLETED
A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
Detailed Description
RISPERDAL CONSTA (risperidone long-acting injection) may provide substantial improvement, by reducing patient non-compliance, in the long-term treatment of bipolar I disorder. This is a randomized (pa...
Eligibility Criteria
Inclusion
- Diagnosis of bipolar 1 disorder, currently experiencing a mixed or manic episode or stable
- Two or more bipolar mood episodes in the last 2 years excluding current episode
- Negative pregnancy test
Exclusion
- History of \> than 4 mood episodes a year during the last two years
- patients experiencing a depressive episode
- History of antisocial or borderline personality illness
- Has unstable or serious general medical illness
- Has received medications disallowed by study criteria.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
559 Patients enrolled
Trial Details
Trial ID
NCT00132678
Start Date
February 1 2005
End Date
December 1 2007
Last Update
July 29 2013
Active Locations (51)
Enter a location and click search to find clinical trials sorted by distance.
1
Little Rock, Arkansas, United States
2
La Mesa, California, United States
3
National City, California, United States
4
Washington D.C., District of Columbia, United States