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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00402584

Purpose

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.

Condition	Intervention	Phase
Binge Eating Disorder Obesity	Drug: sibutramine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders Obesity

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome 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 Outcome 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 ]

Enrollment:	304
Study Start Date:	August 2000

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402584

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Peter Bacher, MD

Abbott

More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00402584 History of Changes
Other Study ID Numbers:	SB237
Study First Received:	November 20, 2006
Last Updated:	August 30, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Bulimia
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorders
Obesity
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 12, 2012