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Treatment of Binge Eating in Obese Patients in Primary Care

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ClinicalTrials.gov Identifier: NCT00537810
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Carlos Grilo, Yale University

Brief Summary:
This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.

Condition or disease Intervention/treatment Phase
Obesity Binge Eating Drug: Sibutramine Drug: Placebo Behavioral: Self-help CBT + Sibutramine Behavioral: Self-help CBT + Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Binge Eating in Obese Patients in Primary Care
Study Start Date : September 2007
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sibutramine
Sibutramine 15 mg daily
Drug: Sibutramine
15 mg daily
Other Name: Meridia

Placebo Comparator: Placebo
Placebo Daily
Drug: Placebo
Daily

Experimental: Placebo/CBTsh
Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Behavioral: Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Experimental: Sibutramine/CBTsh
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Behavioral: Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily




Primary Outcome Measures :
  1. Binge Eating (Remission) [ Time Frame: 4 months treatment; 6 and 12 month follow up post treatment ]
    Remission from binge eating (zero binge episodes during previous 28 days)

  2. BMI [ Time Frame: 4 months treatment ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Obese (BMI >= 30)

Exclusion Criteria:

  • Medication regimen that represents medical contraindication to sibutramine
  • Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
  • Pregnancy

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): NCT00537810


Locations
United States, Connecticut
Yale Internal Medicine Associates (YIMA)
New Haven, Connecticut, United States, 06510
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)
New Haven, Connecticut, United States, 06510
Yale Psychiatric Research at Congress Place
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Carlos M. Grilo, PhD Yale University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carlos Grilo, Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00537810     History of Changes
Other Study ID Numbers: 0501027352
R01DK073542-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2007    Key Record Dates
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Carlos Grilo, Yale University:
Obesity
Binge eating
Sibutramine
Self-help
Primary care

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