Status:
COMPLETED
An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.
Lead Sponsor:
Janssen-Cilag Farmaceutica Ltda.
Conditions:
Binge Eating
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 obes...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00307619
Start Date
November 1 2003
End Date
April 1 2005
Last Update
January 31 2011
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.