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

Tracking Information
First Submitted Date ICMJE	November 20, 2006
First Posted Date ICMJE	November 22, 2006
Last Update Posted Date	August 31, 2007
Study Start Date ICMJE	August 2000
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: August 30, 2007)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: November 20, 2006)	The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
Change History	Complete list of historical versions of study NCT00402584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 30, 2007)	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 ]
Original Secondary Outcome Measures ICMJE; (submitted: November 20, 2006)	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).
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
Official Title ICMJE	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Binge Eating Disorder; Obesity
Intervention ICMJE	Drug: sibutramine
Study Arms	Not Provided
Publications *	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. Epub 2007 Dec 3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: August 30, 2007)	304
Original Enrollment ICMJE; (submitted: November 20, 2006)	300
Study Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00402584
Other Study ID Numbers ICMJE	SB237
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Abbott
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Peter Bacher, MD Abbott
PRS Account	Abbott
Verification Date	August 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP