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

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00402584

First received: November 20, 2006

Last updated: August 30, 2007

Last verified: August 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2006

Last Updated Date

August 30, 2007

Start Date ^ICMJE

August 2000

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

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

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

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

Enrollment ^ICMJE

304

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

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

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

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