Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Bipolar Disorder Clinical Trial

Official title:

Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00294255
• Other study ID #: RIS-USA-T290
• Status: Completed
• Phase: Phase 4
• Start date: March 2003
• Est. completion date: October 2006

Study information

• Verified date: February 2013
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Risperidone
risperidone will be administered 1-3mg pills, each night, for up to 20 weeks

Locations

Country	Name	City	State
United States	University of Texas Health Science Center	San Antonio	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forty percent reduction in YMRS		20 weeks
Secondary	twenty percent reduction in MADRS		20 weeks
Secondary	Remission rate, defined as final score of plus or minus eight on YMRS and MADRS		20 weeks