Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania
Information source: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Risperidone (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: The University of Texas Health Science Center at San Antonio Official(s) and/or principal investigator(s): Vivek Singh, MD, Study Director, Affiliation: UT-SanAntonio Charles Bowden, MD, Principal Investigator, Affiliation: UT San Antonio
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.
Clinical Details
Official title: Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Forty percent reduction in YMRS
Secondary outcome: twenty percent reduction in MADRSRemission rate, defined as final score of plus or minus eight on YMRS and MADRS
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 depressive or irritable symptoms.
- To assess the back ground and baseline features associated with response/non-response
to risperidone plus mood stabilizer in patients with mania with depressive or irritable
features.
- To assess the symptomatic dimensions of response of risperidone added to mood
stabilizers in patients with mania with depressive or irritable features.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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:
-
Locations and Contacts
University of Texas Health Science Center, San Antonio, Texas 78229, United States
Additional Information
Starting date: March 2003
Last updated: February 27, 2013
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