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A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Primary Purpose

Bipolar Disorder, Manic Episode

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Risperidone, oral tablets
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meets DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed hospitalized voluntarily at study initiation for treatment of manic episode history (prior to study initiation) of at least one documented manic or mixed episode that required treatment total score >=20 on the Young Mania Rating Scale (YMRS) at start of the study Exclusion Criteria: Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling borderline or antisocial personality disorder history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation seizure disorder females who are pregnant or nursing, 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 treatment.

    Secondary Outcome Measures

    Change from baseline to end of treatment in Clinical Global Impression-Severity of Illness (CGI-S) scale, Global Assessment Scale (GAS), and Positive and Negative Syndrome Scale (PANSS) total score; incidence of adverse events throughout study.

    Full Information

    First Posted
    November 4, 2005
    Last Updated
    January 13, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00249236
    Brief Title
    A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
    Official Title
    The Efficacy And Safety Of Flexible Dosage Ranges Of Risperidone Versus Placebo In The Treatment Of Manic Or Mixed Episodes Associated With Bipolar I Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2001 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo in treating mania during 3 weeks of treatment in patients with Bipolar I Disorder who suffer from manic or mixed episodes.
    Detailed Description
    Antipsychotic agents have, for a long time, been used to alleviate the severe behavioral problems associated with manic episodes. 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. This is a randomized, double-blind study to evaluate the effectiveness and safety of risperidone compared with placebo in the treatment of patients with bipolar disorder who are experiencing a manic or mixed episode. Patients who are voluntarily hospitalized at the time of study enrollment (for treatment of the manic episode) receive study medication to be taken orally, once a day. Patients receive placebo or risperidone at a starting dose of 3 mg, with gradual dose increases or decreases at the investigator's discretion within the daily dosing range of 1 to 6 mg to achieve optimal effectiveness, while minimizing any intolerance to the drug. Treatment with risperidone or placebo tablets continues for 3 weeks. The primary measure of efficacy is the change from baseline to the end of treatment in the Young Mania Rating Scale (YMRS); Other efficacy assessments include the changes in: the Clinical Global Impression-Severity of Illness (CGI-S) scale; Global Assessment Scale (GAS), which assesses the patient's level of functioning; and the Positive and Negative Syndromes Scale (PANSS), a scale for measuring psychotic symptoms. Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (temperature, pulse, 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) at the start and end of the study. The study hypothesis is that daily treatment with risperidone is more effective than placebo, as measured by Young Mania Rating Scale scores, in the treatment of the manic phase of Bipolar I Disorder. Risperidone oral tablets, 1 mg, taken once daily in the evening; dose of 3 mg on Day 1; dose range of 2 - 4 mg on Day 2; dose range 1 - 5 mg on Day 3; dose range 1 - 6 mg on Days 4 - 21. Doses may be increased or decreased at investigator's discretion.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder, Manic Episode
    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
    291 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Risperidone, oral tablets
    Primary Outcome Measure Information:
    Title
    Change in Young Mania Rating Scale (YMRS) total score from baseline to end of treatment.
    Secondary Outcome Measure Information:
    Title
    Change from baseline to end of treatment in Clinical Global Impression-Severity of Illness (CGI-S) scale, Global Assessment Scale (GAS), and Positive and Negative Syndrome Scale (PANSS) total score; incidence of adverse events throughout study.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meets DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed hospitalized voluntarily at study initiation for treatment of manic episode history (prior to study initiation) of at least one documented manic or mixed episode that required treatment total score >=20 on the Young Mania Rating Scale (YMRS) at start of the study Exclusion Criteria: Meets DSM-IV criteria for Schizoaffective Disorder or for rapid cycling borderline or antisocial personality disorder history of substance dependence (excluding nicotine and caffeine) within the 3 months prior to study initiation seizure disorder females who are pregnant or nursing, or those lacking adequate contraception.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16135859
    Citation
    Khanna S, Vieta E, Lyons B, Grossman F, Eerdekens M, Kramer M. Risperidone in the treatment of acute mania: double-blind, placebo-controlled study. Br J Psychiatry. 2005 Sep;187:229-34. doi: 10.1192/bjp.187.3.229.
    Results Reference
    result
    PubMed Identifier
    16086617
    Citation
    Gopal S, Steffens DC, Kramer ML, Olsen MK. Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy. J Clin Psychiatry. 2005 Aug;66(8):1016-20. doi: 10.4088/jcp.v66n0809.
    Results Reference
    result

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    A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

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