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
Results First Received: June 19, 2014  
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
Conditions: Obesity
Binge Eating
Interventions: Drug: Sibutramine
Drug: Placebo
Behavioral: Self-help CBT + Sibutramine
Behavioral: Self-help CBT + Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Sibutramine     Placebo     Placebo/CBTsh     Sibutramine/CBTsh  
STARTED     26     27     25     26  
COMPLETED     20     14     21     22  
NOT COMPLETED     6     13     4     4  
Withdrawal by Subject                 4                 11                 4                 3  
Medically withdrawn                 2                 2                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Sibutramine     Placebo     Placebo/CBTsh     Sibutramine/CBTsh     Total  
Number of Participants  
[units: participants]
  26     27     25     26     104  
Age  
[units: years]
Mean (Standard Deviation)
  41.2  (10.3)     43.2  (12.4)     45.7  (12.4)     45.6  (9.4)     44.2  (11.1)  
Gender  
[units: participants]
         
Female     19     18     20     16     73  
Male     7     9     5     10     31  
Race/Ethnicity, Customized  
[units: participants]
         
Caucasian     13     12     12     10     47  
African-American     8     12     6     10     36  
Hispanic-American     4     2     4     4     14  
Other     1     1     3     2     7  
Age at onset of Binge Eating Disorder (BED)  
[units: years]
Mean (Standard Deviation)
  25.7  (11.2)     25.5  (11.1)     25.7  (15.1)     29.1  (13.1)     26.2  (12.5)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Binge Eating (Remission)   [ Time Frame: 4 months treatment; 6 and 12 month follow up post treatment ]

2.  Primary:   BMI   [ Time Frame: 4 months treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Carlos Grilo
Organization: Yale University School of Medicine
phone: 2037852792
e-mail: carlos.grilo@yale.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Carlos Grilo, 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