Official Title: “A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder”

The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: sibutramine

Primary Measures

• The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
  • Time Frame: 6 months
    

Secondary Measures

• Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)
  • Time Frame: 6 months
    
• Change from baseline in Body Weight
  • Time Frame: 6 months
    
• Change from baseline in BMI
  • Time Frame: 6 months
    
• Change from baseline in global improvement
  • Time Frame: 6 months
    
• Change from baseline in eating pathology (TFEQ)
  • Time Frame: 6 months
    
• Change from baseline in quality of life (IWQOL-Lite).
  • Time Frame: 6 months
    

Inclusion Criteria:

• Participants were men and women
• between the ages of 18 and 65
• with Body Mass Index (BMI) <45 kg/m2
• who met DSM-IV criteria for BED

Exclusion Criteria:

• Participants were excluded
• for blood pressure >140/90 mm Hg
• with pulse >95 beats/min
• history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction
• use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)
• current participation in a weight loss program
• surgical treatment for obesity
• bulimia nervosa or purging in the past 6 months
• alcohol or drug abuse in the past 12 months
• current psychiatric condition being treated with a psychoactive agent
• current major depressive disorder
• history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts
• psychotherapy within the previous 2 months
• Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Overall Clinical Trial Officials and Contacts

Peter Bacher, MD Study Director Abbott  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00402584

Study ID Number: SB237

ClinicalTrials.gov Identifier: NCT00402584

Health Authority: United States: Food and Drug Administration