A Study of the Effectiveness and Safety of Topiramate in the Treatment of Moderate to Severe Binge-eating Disorder Associated With Obesity

NCT ID: NCT00210808

Last Updated: 2011-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2005-03-31

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in reducing the number of binge days in patients with moderate to severe binge-eating disorder associated with obesity.

Detailed Description

Binge-Eating Disorder (BED) is characterized by recurrent binge eating without extreme behaviors to lose weight (e.g., self-induced vomiting, misuse of laxatives) resulting in marked distress, feelings of loss of control, and association with overweight or obesity. Treatment goals for binge-eating therapies include reducing the urge to binge, weight loss, and management of co-existing medical and psychological conditions. Currently, there are no approved medication treatments available for BED, however, studies have shown that treatment for BED (psychotherapy or the use of medications) may be effective at reducing the number of binges, while effects on weight have been variable. Topiramate has been approved for epilepsy in adults and children aged 2 years and above, and for the prevention of migraine in adults. This is a randomized, double-blind, flexible dose, parallel group study to determine if topiramate, a prescription medication approved by the Food & Drug Administration for the treatment of epilepsy and the prevention of migraine, administered at a dose of 400 mg per day or the subject's maximum tolerated dose, is safe and effective compared with placebo in patients with moderate to severe binge-eating disorder associated with obesity. Subjects will have an equal chance of receiving topiramate or placebo. The study hypothesis is that topiramate will be more effective than placebo in reducing the number of binge days per week in patients with moderate to severe binge-eating disorder associated with obesity and is generally well tolerated. Patients completing the 16-week double-blind phase of the trial are eligible to participate in the 12-week open-label phase of the study.

Topiramate tablets (25 and/or 100 mg) or placebo in increasing doses starting at 25 mg/day up to 400 mg/ day (or MTD) during first 8 wks, achieved dose maintained for additional 8 wks. If entering OL reduce DB medication while increasing dose of active topiramate to 400mg/day or MTD for addn 12 wks.

Conditions

Obesity; Binge-Eating Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

topiramate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Diagnosis of binge-eating disorder
• 3 or more binge days per week in the 2 weeks prior to baseline
• Obese (body mass index >=30 and <=50 kilograms per square meter)
• Uncomplicated/controlled Type II diabetes or hypertension are acceptable
• In generally good health
• If female capable of having children, using acceptable method of birth control

Exclusion Criteria

• No current or past history of schizophrenia, other psychotic disorder, or bipolar disorder
• Significant depression that requires treatment with medication or therapy
• At risk to self or others
• No current or recent (within 3 months) diagnosis of abusing drugs or alcohol
• Initiation of formal psychiatric therapy in past 6 months for binge-eating disorder or any other psychiatric disorder
• Pregnant or breast-feeding
• No clinically significant medical condition

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho-McNeil Neurologics, Inc.

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

McElroy SL, Hudson JI, Capece JA, Beyers K, Fisher AC, Rosenthal NR; Topiramate Binge Eating Disorder Research Group. Topiramate for the treatment of binge eating disorder associated with obesity: a placebo-controlled study. Biol Psychiatry. 2007 May 1;61(9):1039-48. doi: 10.1016/j.biopsych.2006.08.008. Epub 2007 Jan 29.

Reference Type: RESULT

PMID: 17258690 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=614&filename=CR004657_CSR.pdf

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Study to Assess the Safety and Efficacy of Topiramate in the Treatment of Moderate to Severe Binge-Eating Disorder Associated with Obesity

Other Identifiers

CR004657

Identifier Type: -

Identifier Source: org_study_id