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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Treatments: Sibutramine

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