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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00402584
Recruitment Status : Completed
First Posted : November 22, 2006
Last Update Posted : August 31, 2007
Sponsor:
Information provided by:
Abbott

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.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Obesity Drug: sibutramine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Change from baseline in Body Weight [ Time Frame: 6 months ]
  3. Change from baseline in BMI [ Time Frame: 6 months ]
  4. Change from baseline in global improvement [ Time Frame: 6 months ]
  5. Change from baseline in eating pathology (TFEQ) [ Time Frame: 6 months ]
  6. Change from baseline in quality of life (IWQOL-Lite). [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402584


Sponsors and Collaborators
Abbott
Investigators
Study Director: Peter Bacher, MD Abbott

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00402584     History of Changes
Other Study ID Numbers: SB237
First Posted: November 22, 2006    Key Record Dates
Last Update Posted: August 31, 2007
Last Verified: August 2007

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents