Mood Stabilizer in Treatment of Mixed Mania - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder	Drug: Risperidone	Phase IV

MedlinePlus related topics:

Bipolar Disorder

Drug Information available for:

Risperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Risperidone Plus Mood Stabilizer in the Treatment of Mixed Mania

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Forty percent reduction in YMRS and twenty percent reduction in MADRS or OAS

Secondary Outcome Measures:

Change from baseline to final evaluation in YMRS MADRS PANSS OAS and BISS
Remission rate, defined as final score of plus or minus eight on YMRS and MADRS

Estimated Enrollment:	40
Study Start Date:	March 2003
Estimated Study Completion Date:	October 2006

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294255

Locations


United States, Texas
	University of Texas Health Science Center
	San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Janssen, LP

Investigators


Study Director:	Vivek Singh, MD	UT-SanAntonio

Principal Investigator:	Charles Bowden, MD	UT San Antonio

More Information

Study ID Numbers:	RIS-USA-T290
First Received:	September 13, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00294255
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:

mixed mania

depression

irritability

Study placed in the following topic categories:

Affective Disorders, Psychotic

Dopamine

Depression

Mental Disorders

Bipolar Disorder

Risperidone

Mood Disorders

Psychotic Disorders

Depressive Disorder

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Dopamine Antagonists

Antipsychotic Agents

Pharmacologic Actions

Serotonin Antagonists

Serotonin Agents

Therapeutic Uses

Dopamine Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2008

Sponsors and Collaborators:	The University of Texas Health Science Center at San Antonio Janssen, LP
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00294255