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

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag Farmaceutica Ltda.
ClinicalTrials.gov Identifier:
NCT00307619
First received: March 24, 2006
Last updated: January 27, 2011
Last verified: January 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307619

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

No publications provided by Janssen-Cilag Farmaceutica Ltda.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00307619     History of Changes
Other Study ID Numbers: CR003667
Study First Received: March 24, 2006
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Eating Disorders
Hyperphagia
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014