Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Phase 4

Completed

• Conditions: Bipolar Disorder
• Interventions: Drug: Risperidone

• Registration Number: NCT00294255
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-20
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2013-02
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Risperidone	Risperidone	patients will receive risperidone for up to 20 weeks

Primary Outcome Measures

Name	Time	Method
Forty percent reduction in YMRS	20 weeks

Secondary Outcome Measures

Name	Time	Method
twenty percent reduction in MADRS	20 weeks
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS	20 weeks

Trial Locations

Locations (1)

University of Texas Health Science Center; 🇺🇸 San Antonio, Texas, United States