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

November 20, 2006
August 30, 2007
August 2000
Not Provided
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 ]
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals
Complete list of historical versions of study NCT00402584 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)
  • Change from baseline in Body weight
  • Change from baseline in BMI
  • Change from baseline in global improvement
  • Change from baseline in eating pathology (TFEQ)
  • Change from baseline in quality of life (IWQOL-Lite).
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Not Provided
 
A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Binge Eating Disorder
  • Obesity
Drug: sibutramine
Not Provided
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. Epub 2007 Dec 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
Not Provided
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00402584
SB237
No
Not Provided
Abbott
Not Provided
Study Director: Peter Bacher, MD Abbott
Abbott
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP