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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.

Primary Purpose

Bipolar Disorder, Manic Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
risperidone
Sponsored by
Janssen Pharmaceutica N.V., Belgium
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring risperidone, antipsychotic agents, bipolar disorders, manic episode

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    November 4, 2005
    Last Updated
    November 24, 2010
    Sponsor
    Janssen Pharmaceutica N.V., Belgium
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00250367
    Brief Title
    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.
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1997 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 1999 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen Pharmaceutica N.V., Belgium

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder, Manic Disorder
    Keywords
    risperidone, antipsychotic agents, bipolar disorders, manic episode

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    risperidone
    Primary Outcome Measure Information:
    Title
    Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment
    Secondary Outcome Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutica N.V. Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutica N.V.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12562742
    Citation
    Yatham LN, Grossman F, Augustyns I, Vieta E, Ravindran A. Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial. Br J Psychiatry. 2003 Feb;182:141-7. doi: 10.1192/bjp.182.2.141. Erratum In: Br J Psychiatry. 2003 Apr;182:369.
    Results Reference
    result

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    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.

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