An Efficacy and Tolerability Study for Topiramate in Obese Patients With Binge Eating Disorder.
Randomized, Double-blind Placebo Controlled Trial With Topiramate for the Treatment of Obese Patients With Binge Eating Disorder
1 other identifier
interventional
73
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 24, 2006
CompletedFirst Posted
Study publicly available on registry
March 28, 2006
CompletedJanuary 31, 2011
January 1, 2011
March 24, 2006
January 27, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight, Body Mass Index,number of binge eating and anthropometric measurements
Secondary Outcomes (1)
changes in blood pressure, serum triglycerides levels, serum cholesterol levels, beck depression scale scores.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 17915969DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Farmaceutica Ltda. Clinical Trial
Janssen-Cilag Farmaceutica Ltda.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2006
First Posted
March 28, 2006
Study Start
November 1, 2003
Study Completion
April 1, 2005
Last Updated
January 31, 2011
Record last verified: 2011-01