Treatment of Binge Eating in Obese Patients in Primary Care
NCT ID: NCT00537810
Last Updated: 2021-08-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
104 participants
INTERVENTIONAL
2007-09-30
2012-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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Sibutramine
Sibutramine 15 mg daily
Sibutramine
15 mg daily
Placebo
Placebo Daily
Placebo
Daily
Placebo/CBTsh
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
Sibutramine/CBTsh
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily
Interventions
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Sibutramine
15 mg daily
Placebo
Daily
Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
* Pregnancy
18 Years
60 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Carlos Grilo
Professor of Psychiatry
Principal Investigators
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Carlos M. Grilo, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Internal Medicine Associates (YIMA)
New Haven, Connecticut, United States
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)
New Haven, Connecticut, United States
Yale Psychiatric Research at Congress Place
New Haven, Connecticut, United States
Countries
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References
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Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2.
Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043.
Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26.
Other Identifiers
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0501027352
Identifier Type: -
Identifier Source: org_study_id
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