| November 20, 2006 |
| August 30, 2007 |
| August 2000 |
| |
| 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 ]
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- 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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| |
| 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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Binge Eating Disorder
- Obesity
|
| Drug: sibutramine |
| |
| 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. |
| |
| Completed |
| 304 |
|
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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
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00402584 |
|
| SB237 |
| Abbott |
|
| Study Director: |
Peter Bacher, MD |
Abbott |
|
|
| Abbott |
| August 2007 |
