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

August 30, 2007 updated by: Abbott

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: sibutramine

Study Type

Interventional

Enrollment (Actual)

304

Phase

Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	6 months
Change from baseline in Body Weight Time Frame: 6 months	6 months
Change from baseline in BMI Time Frame: 6 months	6 months
Change from baseline in global improvement Time Frame: 6 months	6 months
Change from baseline in eating pathology (TFEQ) Time Frame: 6 months	6 months
Change from baseline in quality of life (IWQOL-Lite). Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

Study Director: Peter Bacher, MD, Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1176/appi.ajp.2007.06121970. Epub 2007 Dec 3.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria