Treatment of Binge Eating in Obese Patients in Primary Care

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Carlos Grilo, Yale University
ClinicalTrials.gov Identifier:
NCT00537810
First received: September 27, 2007
Last updated: December 11, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Obesity
Binge Eating
Drug: Sibutramine
Drug: Placebo
Behavioral: Self-help CBT + Sibutramine
Behavioral: Self-help CBT + Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Binge Eating in Obese Patients in Primary Care

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Binge Eating (Remission) [ Time Frame: 4 months treatment; 6 and 12 month follow up post treatment ] [ Designated as safety issue: No ]
    Remission from binge eating (zero binge episodes during previous 28 days)

  • BMI [ Time Frame: 4 months treatment ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: September 2007
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537810

Locations
United States, Connecticut
Yale Internal Medicine Associates (YIMA)
New Haven, Connecticut, United States, 06510
Yale Psychiatric Research at Congress Place
New Haven, Connecticut, United States, 06519
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Carlos M. Grilo, PhD Yale University
  More Information

Publications:
Additional 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
Study First Received: September 27, 2007
Results First Received: June 19, 2014
Last Updated: December 11, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Eating Disorders
Hyperphagia
Mental Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Sibutramine
Anti-Obesity Agents
Antidepressive Agents
Appetite Depressants
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 28, 2015