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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: risperidone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00216554

CR005068

Details and patient eligibility

About

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

Full 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

Enrollment

118 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.