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Trial record 46 of 592 for:    binge eating disorder

Study of Duloxetine vs Placebo in Treatment of Binge Eating Disorder With Depression

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ClinicalTrials.gov Identifier: NCT00607789
Recruitment Status : Completed
First Posted : February 6, 2008
Results First Posted : November 14, 2012
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Erik Nelson, University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Binge Eating
Depression
Interventions Drug: Duloxetine
Drug: Placebo
Enrollment 40
Recruitment Details All participants were recruited at the Lindner Center of HOPE location.
Pre-assignment Details 64 participants were consented. 24 were not randomised: 21 did not meet entry criteria and 3 withdrew consent.
Arm/Group Title Duloxetine Group Placebo Group
Hide Arm/Group Description 30-120 mg/day of duloxetine during a 12-week period Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
Period Title: Overall Study
Started 20 [1] 20
Completed 13 14
Not Completed 7 6
Reason Not Completed
Adverse Event             3             0
Lack of Efficacy             0             1
Inadequate adherence             3             0
Lost to Follow-up             0             5
Withdrawal by Subject             1             0
[1]
20 participants were randomized in each group
Arm/Group Title Duloxetine Group Placebo Group Total
Hide Arm/Group Description Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
40
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
44.4  (12.1) 35.7  (10.4) 40.05  (11.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
16
  80.0%
19
  95.0%
35
  87.5%
Male
4
  20.0%
1
   5.0%
5
  12.5%
1.Primary Outcome
Title Binge Eating Days
Hide Description The mean number of binge days (days when the participant had one or more binge eating episodes) per week in the interval between visits (total number of binge days in the interval divided by number of days in the interval, then multiplied by 7).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups.
Arm/Group Title Duloxetine Group Placebo Group
Hide Arm/Group Description:
Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Mean Number of days
4.3  (1.7) 3.8  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Duloxetine Group, Placebo Group
Comments The primary efficacy analysis was a longitudinal analysis comparing the rate of change of binge day frequency during the treatment period between groups. The same analysis was applied to binge episode frequency, weight, BMI, and scores on the CGI-Severity, YBOCS-BE, and IDS scales. The difference in rate of change was estimated by random regression methods
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.3
Parameter Dispersion
Type: Standard Deviation
Value: 1.7
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Weekly Episodes
Hide Description The weekly frequency of binge episodes after baseline (number of binge eating days during the 12-week period divided by 7)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The secondary efficacy analysis was a longitudinal analysis comparing the rate of change of binge weeks frequency during the treatment period between groups.
Arm/Group Title Duloxetine Group Placebo Group
Hide Arm/Group Description:
Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Days
4.7  (1.9) 4.2  (2.6)
Time Frame 12 weeks
Adverse Event Reporting Description The most frequent adverse events were: constipation, dry mouth, hyperhydrosis, and nausea.
 
Arm/Group Title Duloxetine Group Placebo Group
Hide Arm/Group Description Participants randomized to 30-120 mg/day of duloxetine for 12 weeks. Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
All-Cause Mortality
Duloxetine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      0/20 (0.00%)    
Gastrointestinal disorders     
Gastrointestinal problems  [1]  1/20 (5.00%)  1 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Sinus Infection  [2]  1/20 (5.00%)  1 0/20 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant required a 48-hour hospitalization; the participant recovered fully and the event was thought not to be due to duloxetine.
[2]
Participant who experienced gastrointestinal problems also had a sinus infection.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.05%
Duloxetine Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      8/20 (40.00%)    
Endocrine disorders     
Hyperhydrosis  [1]  5/20 (25.00%)  5 2/20 (10.00%)  2
Gastrointestinal disorders     
Nausea   9/20 (45.00%)  9 3/20 (15.00%)  3
Constipation   5/20 (25.00%)  5 1/20 (5.00%)  1
General disorders     
Dry Mouth   7/20 (35.00%)  7 2/20 (10.00%)  2
Indicates events were collected by systematic assessment
[1]
Excessive sweating
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
All trial data will be posted & published by the Lindner Center of HOPE (PI: Dr. Susan McElroy)
Results Point of Contact
Name/Title: Susan McElroy, MD
Organization: Lindner Center of HOPE
Phone: 513-536-0718
Responsible Party: Erik Nelson, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00607789     History of Changes
Other Study ID Numbers: Nelson #2
First Submitted: January 23, 2008
First Posted: February 6, 2008
Results First Submitted: March 8, 2011
Results First Posted: November 14, 2012
Last Update Posted: August 21, 2017