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Clinical Trial Summary

This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.


Clinical Trial Description

The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00829283
Study type Interventional
Source Yale University
Contact
Status Completed
Phase N/A
Start date November 2008
Completion date November 2013

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