Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine in patients experiencing a manic episode with depressive or irritable features.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: Janssen, LP
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic

• YMRS score>/= 16

• One or more of following:

1. 3 MADRS depression items scoring >/=3

2. 3 BISS depression items scoring >/=3

3. YMRS irritability and aggressive items sum score>/=4

• Taking lithium, valproate or lamotrigine at stable dose for 4 wks or longer, with adequate serum level

• age 18 and over

• Male or female

• Inpatient or outpatient

Exclusion Criteria:

-