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An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.

Primary Purpose

Binge Eating

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
topiramate
Sponsored by
Janssen-Cilag Farmaceutica Ltda.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating focused on measuring Binge-Eating Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Have been meeting the diagnostic criteria for binge eating disorder (according to the Diagnostic and Statistical Manual for Mental Disorders - IV Edition criteria) with at least 2 days of binge eating per week and severity at least moderate defined by binge eating scale (score = 17) BMI = > 30 kg/m2 to < 46 kg/m2 Women must be post menopausal for at least one year or surgically sterilized (hysterectomy, tubal ligation), or practice sexual abstinence or use an acceptable method of birth control (i.e. a hormonal contraceptive, spermicide plus barrier method, intrauterine device and/or vasectomized partner) Exclusion Criteria: Has a history or actual diagnostic of significant psychiatric disorder (schizophrenia, psychosis, major affective disorder, suicide risk, dementia, abuses alcohol or other drugs) has a malignancy or a history of malignancy within the past 5 years (except basal cell carcinoma) evidence of uncontrolled thyroid disorders uncontrolled hypertension (defined as a diastolic blood pressure >110 mm/Hg and/or a systolic blood pressure >180 mm/Hg with or without medication). Hypertensive patients on medications must have been on the same dose of the same antihypertensive medication for at least two months history or significant renal failure or glaucoma.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Weight, Body Mass Index,number of binge eating and anthropometric measurements

    Secondary Outcome Measures

    changes in blood pressure, serum triglycerides levels, serum cholesterol levels, beck depression scale scores.

    Full Information

    First Posted
    March 24, 2006
    Last Updated
    January 27, 2011
    Sponsor
    Janssen-Cilag Farmaceutica Ltda.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00307619
    Brief Title
    An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.
    Official Title
    Randomized, Double-blind Placebo Controlled Trial With Topiramate for the Treatment of Obese Patients With Binge Eating Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    April 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Janssen-Cilag Farmaceutica Ltda.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the effectiveness and tolerability of topiramate compared to placebo in patients with binge eating disorder receiving Cognitive Behavior Therapy (CBT)
    Detailed Description
    This was a 21-week multicenter, double-blind, parallel-group, randomized controlled trial comparing the efficacy and tolerability of an add-on treatment with 200mg of topiramate versus placebo in obese patients with BED receiving group CBT. The aim of this trial is to investigate the efficacy and tolerability of adjunctive topiramate to CBT in obese patients with BED through improvement in binge eating, related psychopathology, and weight loss. The study hypothesis is that the patients using topiramate + CBT will loose more weight than patients using placebo + CBT.Tolerability will be investigated through reported adverse events and dropouts, with reasons for leaving the study being analyzed. The randomized patients will receive capsules of topiramate (25 mg, 50 mg) or placebo correspondent daily for 21 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Binge Eating
    Keywords
    Binge-Eating Disorder

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    topiramate
    Primary Outcome Measure Information:
    Title
    Weight, Body Mass Index,number of binge eating and anthropometric measurements
    Secondary Outcome Measure Information:
    Title
    changes in blood pressure, serum triglycerides levels, serum cholesterol levels, beck depression scale scores.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have been meeting the diagnostic criteria for binge eating disorder (according to the Diagnostic and Statistical Manual for Mental Disorders - IV Edition criteria) with at least 2 days of binge eating per week and severity at least moderate defined by binge eating scale (score = 17) BMI = > 30 kg/m2 to < 46 kg/m2 Women must be post menopausal for at least one year or surgically sterilized (hysterectomy, tubal ligation), or practice sexual abstinence or use an acceptable method of birth control (i.e. a hormonal contraceptive, spermicide plus barrier method, intrauterine device and/or vasectomized partner) Exclusion Criteria: Has a history or actual diagnostic of significant psychiatric disorder (schizophrenia, psychosis, major affective disorder, suicide risk, dementia, abuses alcohol or other drugs) has a malignancy or a history of malignancy within the past 5 years (except basal cell carcinoma) evidence of uncontrolled thyroid disorders uncontrolled hypertension (defined as a diastolic blood pressure >110 mm/Hg and/or a systolic blood pressure >180 mm/Hg with or without medication). Hypertensive patients on medications must have been on the same dose of the same antihypertensive medication for at least two months history or significant renal failure or glaucoma.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen-Cilag Farmaceutica Ltda. Clinical Trial
    Organizational Affiliation
    Janssen-Cilag Farmaceutica Ltda.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17915969
    Citation
    Claudino AM, de Oliveira IR, Appolinario JC, Cordas TA, Duchesne M, Sichieri R, Bacaltchuk J. Double-blind, randomized, placebo-controlled trial of topiramate plus cognitive-behavior therapy in binge-eating disorder. J Clin Psychiatry. 2007 Sep;68(9):1324-32. doi: 10.4088/jcp.v68n0901.
    Results Reference
    derived

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    An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.

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