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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 MADRS

Remission 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

Page last updated: August 23, 2015

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