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A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

Primary Purpose

Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Topiramate
Placebo
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Mania, Pediatric, Children, Adolescent, Topiramate, Anticonvulsants, Central Nervous System Agents, Protective Agents, Neuroprotectiive Agents

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version [K-SADS-P/L]) YMRS score greater than or equal to 20 General good health as determined by medical history, physical examination, and laboratory evaluations Ability to swallow tablets Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients Exclusion Criteria: DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS) DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis Weight less than 33 kg or current or past history of anorexia nervosa Serious or unstable medical or neurological conditions

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    001

    002

    Arm Description

    Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.

    Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

    Outcomes

    Primary Outcome Measures

    Change from baseline in total Young Mania Rating Scale (YMRS) score

    Secondary Outcome Measures

    Change from baseline in Clinical Global Impression Scale (CGI-S) score
    Change from baseline in Children's Global Assessment Scale (C-GAS) score
    The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder

    Full Information

    First Posted
    May 6, 2002
    Last Updated
    June 23, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00035802
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
    Official Title
    A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2002 (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 this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
    Detailed Description
    This is a 4-week study to evaluate the safety and effectiveness of topiramate compared to placebo in the treatment of Bipolar I Disorder with an optional 6-month open-label (OL) extension for qualified patients following completion of the study. On Days 1-28 patients will receive placebo or topiramate 2x/day by mouth except for the 1st and last doses which will be a single evening dose and a single morning dose, respectively. Study drug will be titrated in 100-mg increments to 400 mg/day and patients maintained on a stable dose through Day 28. During the OL extension phase, topiramate will be titrated over 5 days to 200 mg/day. After Day 7, topiramate may be tapered down to 100 mg/day or up to 600 mg/day, as clinically indicated.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
    Keywords
    Bipolar, Mania, Pediatric, Children, Adolescent, Topiramate, Anticonvulsants, Central Nervous System Agents, Protective Agents, Neuroprotectiive Agents

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    13 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    001
    Arm Type
    Experimental
    Arm Description
    Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.
    Arm Title
    002
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Topiramate
    Intervention Description
    Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.
    Primary Outcome Measure Information:
    Title
    Change from baseline in total Young Mania Rating Scale (YMRS) score
    Time Frame
    Baseline to Day 28 (or last available observation prior to Day 28).
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Clinical Global Impression Scale (CGI-S) score
    Time Frame
    Baseline to Day 28 (or last available observation prior to Day 28).
    Title
    Change from baseline in Children's Global Assessment Scale (C-GAS) score
    Time Frame
    Baseline to Day 28 (or last available observation prior to Day 28).
    Title
    The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder
    Time Frame
    Day 28 (or last available observation prior to Day 28)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version [K-SADS-P/L]) YMRS score greater than or equal to 20 General good health as determined by medical history, physical examination, and laboratory evaluations Ability to swallow tablets Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients Exclusion Criteria: DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS) DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within the 3 months prior to baseline. Acute or intermittent substance abuse prior to screening will not be exclusionary, depending upon the clinical judgment of the investigator Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis Weight less than 33 kg or current or past history of anorexia nervosa Serious or unstable medical or neurological conditions
    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

    Learn more about this trial

    A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

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