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
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Binge-Eating Disorder
Eating Disorders
Obesity
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 27, 2014