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

Abbott

Status and phase

Completed

Phase 3

Conditions

Obesity

Binge Eating Disorder

Treatments

Drug: sibutramine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00402584

SB237

Details and patient eligibility

About

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.

Enrollment

304 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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