A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

Phase 3

Completed

• Conditions: Binge Eating Disorder; Obesity

• Registration Number: NCT00402584
• Lead Sponsor: Abbott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-08
• Study First Submitted: 2006-11-20
• Study First Submitted QC: 2006-11-20
• Study First Posted: 2006-11-22
• Status Verified: 2007-08
• Last Update Submitted: 2007-08-30
• Last Update Posted: 2007-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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