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

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ClinicalTrials.gov Identifier: NCT00216554
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : January 24, 2011
Information provided by:
Janssen Korea, Ltd., Korea

September 13, 2005
September 22, 2005
January 24, 2011
September 2004
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The change in YMRS score from baseline at 6 months
Same as current
Complete list of historical versions of study NCT00216554 on ClinicalTrials.gov Archive Site
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
Same as current
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The Safety and Efficacy of Risperidone as Adjunctive Therapy to Mood Stabilizers in the Long-term Treatment of Bipolar Mania
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
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

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

Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bipolar Disorder
Drug: risperidone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2006
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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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Korea, Republic of
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Janssen Korea, Ltd., Korea
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Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd.
Janssen Korea, Ltd., Korea
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP