The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-Term Treatment of Bipolar Mania - Full Text View

Sponsored by:	Janssen Korea, Ltd., Korea
Information provided by:	Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:	NCT00216554

Purpose

The purpose of this study is to evaluate effect of risperidone as a long-term combination therapy to mood stabilizers in the treatment of bipolar mania

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, Efficacy Study
Official Title:	A Multicenter, Open-Label Study to Evaluate Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-Term Treatment of Bipolar Mania

Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:

The change in YMRS score from baseline at 6 months

Secondary Outcome Measures:

The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 6 months; The change from baseline in HAMD score at 6 months

Estimated Enrollment:	128
Study Start Date:	September 2004
Estimated Study Completion Date:	March 2006

Detailed Description:

The use of mood stabilizers such as lithium and carbamazepine is known to be effective for preventing and treating bipolar disorder. But the use of antipsychotic drugs is more effective in patients suffering severe episodes of mania as it elicits behavioral changes and spurs the effects of mood stabilizers. Antipsychotic drugs are used for patients who failed to respond to mood stabilizers or for the acute management of manic episodes associated with bipolar disorders. This study aims to evaluate the safety and efficacy of risperidone as an adjunctive therapy to mood stabilizers in the long-term treatment (6months) of bipolar disorder using various assessment instruments, including the Young Mania Rating Scale. The Simpson-Angus Rating Scale will be also employed to assess the presence of extrapyramidal side effects and other adverse events.

The patients will receive orally 0.5, 1, 2 mg risperidone tablet once daily for 6 months

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

In- or out-patient - Diagnosis of bipolar I disorder - Most recent episode manic with or without psychotic features - YMRS > 20 (manic) - Need antipsychotic combination on the basis of clinicians' experience

Exclusion Criteria:

Rapid cycling - Risk of suicide or violence - History of Substance dependence within 3 months - Comorbidities - Unstable medical illness - Previous sensitivity history to risperidone
Pregnant woman or those without proper contraception - History of clozapine and one cycle of depot use prior to entry - History of treatment resistance: at least two mood stabilizers - Prior history of active treatment with risperidone - As for patients having wash-out period, patients that show 25% or more decrease in YMRS at baseline as compared to that at enrollment time, should be excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00216554

Sponsors and Collaborators

Janssen Korea, Ltd., Korea

Investigators

Study Director:

Janssen Korea, Ltd. Clinical Trial

Janssen Korea, Ltd., Korea

More Information

Study ID Numbers:	CR005068
Study First Received:	September 13, 2005
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00216554
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:

Adjunctive therapy
Bipolar
risperidone

Study placed in the following topic categories:

Affective Disorders, Psychotic
Dopamine
Mental Disorders
Bipolar Disorder

Risperidone
Mood Disorders
Psychotic Disorders
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 January 14, 2009