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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00216554

Enrollment

118

Registered

2005-09-22

Start date

2004-09-30

Completion date

2006-03-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar, risperidone, Adjunctive therapy

Brief summary

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

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

Interventions

DRUGrisperidone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
The change in YMRS score from baseline at 6 months	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026