NCT00294255

Risperidone Plus Mood Stabilizer in Treatment of Mixed Mania

Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Risperidone	risperidone will be administered 1-3mg pills, each night, for up to 20 weeks

Timeline

• Start date: 2003-03-01
• Primary completion: 2006-10-01
• Completion: 2006-10-01
• First posted: 2006-02-20
• Last updated: 2018-06-14

Locations

1 site across 1 country: United States