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The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00216554
First Posted: September 22, 2005
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Janssen Korea, Ltd., Korea
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Enrollment: 118
Study Start Date: September 2004
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216554


Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
  More Information

ClinicalTrials.gov Identifier: NCT00216554     History of Changes
Other Study ID Numbers: CR005068
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by Janssen Korea, Ltd., Korea:
Bipolar
risperidone
Adjunctive therapy

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents


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