Status:
COMPLETED
Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Janssen, LP
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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.
Detailed Description
* The study aims to assess the efficacy and tolerability of risperidone added to lithium, valproate or lamotrigine, or any combination of the three, in patients experiencing a manic episode with depre...
Eligibility Criteria
Inclusion
- DSM IV diagnosis of bipolar disorder, currently manic, or mixed manic
- YMRS score\>/= 16
- One or more of following:
- 3 MADRS depression items scoring \>/=3
- 3 BISS depression items scoring \>/=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
- \-
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00294255
Start Date
March 1 2003
End Date
October 1 2006
Last Update
June 14 2018
Active Locations (1)
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1
University of Texas Health Science Center
San Antonio, Texas, United States, 78229