Back to resultsA Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
Primary Purpose
Binge Eating Disorder, Obesity
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sibutramine
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Disorder
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00402584
Brief Title
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
sibutramine
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
Change from baseline in Body Weight
Time Frame
6 months
Title
Change from baseline in BMI
Time Frame
6 months
Title
Change from baseline in global improvement
Time Frame
6 months
Title
Change from baseline in eating pathology (TFEQ)
Time Frame
6 months
Title
Change from baseline in quality of life (IWQOL-Lite).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Bacher, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18056225
Citation
Wilfley DE, Crow SJ, Hudson JI, Mitchell JE, Berkowitz RI, Blakesley V, Walsh BT; Sibutramine Binge Eating Disorder Research Group. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry. 2008 Jan;165(1):51-8. doi: 10.1176/appi.ajp.2007.06121970. Epub 2007 Dec 3.
Results Reference
derived
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A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
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