A Study of the Effectiveness and Safety of Risperidone Versus Placebo as add-on Therapy to Mood Stabilizers, in the Treatment of Manic Episodes Associated With Bipolar Disorder.

November 24, 2010 updated by: Janssen Pharmaceutica N.V., Belgium

The Safety And Efficacy Of Risperdal� (Risperidone) Versus Placebo As Add-On Therapy To Mood Stabilizers In The Treatment Of The Manic Phase Of Bipolar Disorder

The purpose of the study is to evaluate the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo as add-on therapy to mood stabilizers, in the treatment of manic episodes associated with bipolar disorder.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Risperidone, widely used in the treatment of schizophrenia, has been shown to be effective in the treatment of manic and mixed episodes associated with bipolar disorders. Antipsychotic drugs like risperidone have also been used as therapeutic agents in the treatment of patients who are not responsive to mood stabilizers alone. This is a randomized, double-blind study to evaluate the effectiveness and safety of risperidone compared with placebo, as an addition to mood stabilizing drugs, in the treatment of patients experiencing manic episodes associated with bipolar disorder. The study has two phases: a double-blind treatment phase (3 weeks) and an open-label phase (10 weeks). To participate in the study, patients must be in-patients for a minimum of the first 4 days of double-blind treatment. During the double-blind treatment phase, patients receive risperidone or placebo tablets to be taken once a day at gradually increasing doses at investigator's discretion, up to a maximum dose of 6 mg/day, while continuing their treatment with a mood stabilizer (lithium, valproate, or carbamazepine). In the open-label phase, therapy with a mood stabilizer continues, and all patients receive risperidone with dosage gradually adjusted to achieve optimal effectiveness. The primary measure of effectiveness is the change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment. Additional efficacy measures include the Brief Psychiatric Rating Scale (BPRS), the Clinical Global Impression (CGI), (which evaluates the change in severity of the disorder), and the Hamilton Depression Rating Scale (HAMD). Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (pulse and blood pressure) and evaluation of the presence and severity of extrapyramidal symptoms by the Extrapyramidal Symptom Rating Scale (ESRS) at specified intervals; and clinical laboratory tests (hematology, biochemistry, urinalysis) before study initiation, at completion of the double-blind treatment, and at the end of the study. The study hypothesis is that daily treatment with risperidone as add-on therapy provides better effectiveness than the addition of placebo, as measured by Young Mania Rating Scale scores, in the treatment of the manic phase of bipolar disorder. Risperidone 1 mg tablets, taken orally, once daily; Doses of 2 mg on Days 1 and 2, up to 4 mg on Days 3 and 4, and up to 6 mg (maximum dose) on Days 5 through 21. Same dose maintained through the 10 week open-label phase. Gradual dose adjustments are allowed to achieve optimal effectiveness.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients hospitalized for mania with a score >=20 on the Young Mania Rating Scale (YMRS). (Patients with symptoms of depression are eligible)
  • diagnosis of Bipolar Disorder according to Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
  • receiving treatment with a mood stabilizer for a minimum of 2 weeks prior to study initiation, or beginning therapy with a mood stabilizer prior to treatment with study medication
  • patients medically stable on the basis of physical examination, medical history and electrocardiogram results.

Exclusion Criteria:

  • Other Axis I DSM-IV diagnosis (except nicotine or caffeine dependence)
  • history of alcohol or drug abuse or dependence within 3 months of starting the study
  • seizure disorder requiring medication
  • known sensitivity to risperidone, lithium, valproate or carbamazepine
  • pregnant or nursing females, or those lacking adequate contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment

Secondary Outcome Measures

Outcome Measure
Changes from baseline to end of double-blind treatment in Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI) - severity, and Hamilton Depression Rating Scale (HAMD); incidence of adverse events throughout study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Pharmaceutica N.V., Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Study Completion (Actual)

November 1, 1999

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 4, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Estimate)

November 25, 2010

Last Update Submitted That Met QC Criteria

November 24, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR006058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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