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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00307619
First Posted: March 28, 2006
Last Update Posted: January 31, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Janssen-Cilag Farmaceutica Ltda.
  Purpose
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)

Condition Intervention Phase
Binge Eating Drug: topiramate Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Randomized, Double-blind Placebo Controlled Trial With Topiramate for the Treatment of Obese Patients With Binge Eating Disorder

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Farmaceutica Ltda.:

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.

Enrollment: 73
Study Start Date: November 2003
Study Completion Date: April 2005
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307619


Sponsors and Collaborators
Janssen-Cilag Farmaceutica Ltda.
Investigators
Study Director: Janssen-Cilag Farmaceutica Ltda. Clinical Trial Janssen-Cilag Farmaceutica Ltda.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00307619     History of Changes
Other Study ID Numbers: CR003667
First Submitted: March 24, 2006
First Posted: March 28, 2006
Last Update Posted: January 31, 2011
Last Verified: January 2011

Keywords provided by Janssen-Cilag Farmaceutica Ltda.:
Binge-Eating Disorder

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Topiramate
Anticonvulsants
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents