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Trial record 74 of 592 for:    binge eating disorder

Treatment of Binge Eating in Obese Patients in Primary Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 104
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Hide Arm/Group Description

Sibutramine 15 mg daily

Sibutramine: 15 mg daily

Placebo Daily

Placebo: Daily

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 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

Period Title: Overall Study
Started 26 27 25 26
Completed 20 14 21 22
Not Completed 6 13 4 4
Reason Not Completed
Withdrawal by Subject             4             11             4             3
Medically withdrawn             2             2             0             1
Arm/Group Title Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh Total
Hide Arm/Group Description

Sibutramine 15 mg daily

Sibutramine: 15 mg daily

Placebo Daily

Placebo: Daily

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 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 of all reporting groups
Overall Number of Baseline Participants 26 27 25 26 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 25 participants 26 participants 104 participants
41.2  (10.3) 43.2  (12.4) 45.7  (12.4) 45.6  (9.4) 44.2  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 25 participants 26 participants 104 participants
Female
19
  73.1%
18
  66.7%
20
  80.0%
16
  61.5%
73
  70.2%
Male
7
  26.9%
9
  33.3%
5
  20.0%
10
  38.5%
31
  29.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 26 participants 27 participants 25 participants 26 participants 104 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)  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 27 participants 25 participants 26 participants 104 participants
25.7  (11.2) 25.5  (11.1) 25.7  (15.1) 29.1  (13.1) 26.2  (12.5)
1.Primary Outcome
Title Binge Eating (Remission)
Hide Description Remission from binge eating (zero binge episodes during previous 28 days)
Time Frame 4 months treatment; 6 and 12 month follow up post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Hide Arm/Group Description:

Sibutramine 15 mg daily

Sibutramine: 15 mg daily

Placebo Daily

Placebo: Daily

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 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

Overall Number of Participants Analyzed 26 27 25 26
Measure Type: Number
Unit of Measure: participants
Remission at Post-treatment 10 8 6 6
Remission at 6 month follow up 5 11 10 13
Remission at 12 month follow up 5 10 10 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sibutramine, Placebo, Placebo/CBTsh, Sibutramine/CBTsh
Comments Post-treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Chi-squared
Comments df=3
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sibutramine, Placebo, Placebo/CBTsh, Sibutramine/CBTsh
Comments 6 month follow up
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Chi-squared
Comments df=3
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sibutramine, Placebo, Placebo/CBTsh, Sibutramine/CBTsh
Comments 12 month follow up
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method Chi-squared
Comments df=3
2.Primary Outcome
Title BMI
Hide Description [Not Specified]
Time Frame 4 months treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with complete data reported here (i.e., no imputation)
Arm/Group Title Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Hide Arm/Group Description:

Sibutramine 15 mg daily

Sibutramine: 15 mg daily

Placebo Daily

Placebo: Daily

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 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

Overall Number of Participants Analyzed 21 19 22 22
Mean (Standard Deviation)
Unit of Measure: BMI (kg/m^2)
38.4  (7.2) 39.6  (5.7) 35.9  (5.6) 35.6  (4.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Hide Arm/Group Description

Sibutramine 15 mg daily

Sibutramine: 15 mg daily

Placebo Daily

Placebo: Daily

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 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

All-Cause Mortality
Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/27 (0.00%)   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sibutramine Placebo Placebo/CBTsh Sibutramine/CBTsh
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/26 (3.85%)   2/27 (7.41%)   0/25 (0.00%)   1/26 (3.85%) 
Vascular disorders         
Elevated blood pressure  [1]  1/26 (3.85%)  2/27 (7.41%)  0/25 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
[1]
Patients medically withdrawn due to elevation in blood pressure during treatment (i.e., in excess of 145/90 BP, 100 pulse)
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
Responsible Party: Carlos Grilo, Yale University
ClinicalTrials.gov Identifier: NCT00537810     History of Changes
Other Study ID Numbers: 0501027352
R01DK073542-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2007
First Posted: October 1, 2007
Results First Submitted: June 19, 2014
Results First Posted: December 12, 2014
Last Update Posted: December 12, 2014