A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Binge Eating Disorder; Obesity
Intervention: sibutramine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s):
Peter Bacher, MD, Study Director, Affiliation: Abbott
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
Secondary outcome: Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)Change from baseline in Body Weight Change from baseline in BMI Change from baseline in global improvement Change from baseline in eating pathology (TFEQ) Change from baseline in quality of life (IWQOL-Lite).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: August 2000
Last updated: August 30, 2007
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