A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.