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Trial record 5 of 1269 for:    depression AND Major Depression AND depressive symptoms | "Depression"

Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression (IBS-MDD)

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ClinicalTrials.gov Identifier: NCT01754493
Recruitment Status : Completed
First Posted : December 21, 2012
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Major Depression
Irritable Bowel Syndrome
Intervention Drug: Duloxetine
Enrollment 17

Recruitment Details Study participants were recruited through print and electronic advertisements (n=12). We also received referrals from community clinicians (n=3), a former patient (n=1) and a psychiatric help line (n=1). Recruitment took place from 1/19/07 to 5/20/14.
Pre-assignment Details This study was a single-arm open trial, so all the participants were assigned to the open-label duloxetine treatment arm.
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Period Title: Overall Study
Started 17
Completed 10
Not Completed 7
Reason Not Completed
Adverse Event             1
Lost to Follow-up             3
Withdrawal by Subject             1
Moved out of town             1
Scheduling conflict             1
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants
42.7  (11.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
13
  76.5%
Male
4
  23.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Hispanic or Latino
17
 100.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants
17
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.
Time Frame Weeks 0, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description:

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 Number Analyzed 17 participants
31.59  (8.46)
Week 8 Number Analyzed 12 participants
15.67  (11.39)
Week 12 Number Analyzed 10 participants
11.4  (6.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total MADRS symptom scores for MDD. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -18.24
Confidence Interval (2-Sided) 95%
-23.44 to -12.63
Estimation Comments [Not Specified]
2.Primary Outcome
Title Gastrointestinal Symptoms Rating Scale (GSRS)
Time Frame Weeks 0, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description:

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 Number Analyzed 17 participants
54.76  (15.45)
Week 8 Number Analyzed 12 participants
36.33  (13.93)
Week 12 Number Analyzed 10 participants
31.4  (12.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in total GSRS symptom scores for IBS. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -20.71
Confidence Interval (2-Sided) 95%
-27.44 to -13.97
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Clinician-Rated Global Impression Scales (CGI)
Hide Description Two clinician-administered scales measuring level of change in (1) depressive symptoms and (2) IBS symptoms, assessed separately. Range is 1-7, ranging from very much improved (1) to very much worsened (7).
Time Frame Measured at weeks 0, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description:

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
CGI - Major Depression, Week 0 Number Analyzed 17 participants
4.71  (0.85)
CGI - Major Depression, Week 8 Number Analyzed 12 participants
3.58  (0.67)
CGI - Major Depression, Week 12 Number Analyzed 10 participants
3  (0.94)
CGI - IBS, Week 0 Number Analyzed 17 participants
4.65  (0.70)
CGI - IBS, Week 8 Number Analyzed 12 participants
3.58  (0.67)
CGI - IBS, Week 12 Number Analyzed 10 participants
3  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-MDD score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.59
Confidence Interval (2-Sided) 95%
-2.16 to -1.03
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in CGI-IBS score. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-1.99 to -1.11
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Visual Analogue Scales (VAS)
Hide Description Five self-report 11-point Likert scales measuring pain severity in the following domains (one item each): overall pain, pain interfering with daily activities, headaches, back pain, and shoulder pain. Range is 0-10; higher scores indicate higher pain severity.
Time Frame Measured at weeks 0, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description:

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Overall pain, Week 0 Number Analyzed 17 participants
5  (2.62)
Pain interfering with daily activities, Week 0 Number Analyzed 16 participants
4.94  (3.42)
Headaches, Week 0 Number Analyzed 17 participants
4.24  (2.19)
Back pain, Week 0 Number Analyzed 17 participants
5.47  (2.62)
Shoulder pain, Week 0 Number Analyzed 17 participants
5.29  (3.21)
Overall pain, Week 8 Number Analyzed 12 participants
6.08  (2.11)
Pain interfering with daily activities, Week 8 Number Analyzed 12 participants
6  (2.70)
Headaches, Week 8 Number Analyzed 12 participants
4.5  (2.97)
Back pain, Week 8 Number Analyzed 12 participants
5.58  (3)
Shoulder pain, Week 8 Number Analyzed 12 participants
5.17  (3.07)
Overall pain, Week 12 Number Analyzed 10 participants
4.1  (3)
Pain interfering with daily activities, Week 12 Number Analyzed 10 participants
4.8  (3.01)
Headaches, Week 12 Number Analyzed 10 participants
3.4  (2.63)
Back pain, Week 12 Number Analyzed 10 participants
4.9  (3.03)
Shoulder pain, Week 12 Number Analyzed 10 participants
4.7  (3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of overall pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.03
Confidence Interval (2-Sided) 95%
-1.16 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This repeated-measures mixed-effects regression analysis assessed the rate of change in VAS score of pain interfering with daily activities. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a 1st-order autocorrelation structure. Data from each time point (wks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value .47
Confidence Interval (2-Sided) 95%
-1.07 to 2.01
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of headaches. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.59
Confidence Interval (2-Sided) 95%
-2.28 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of back pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.35
Confidence Interval (2-Sided) 95%
-1.56 to .87
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample, including all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in VAS score of shoulder pain. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -.48
Confidence Interval (2-Sided) 95%
-2.00 to 1.03
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Somatization Module of the Patient's Health Questionnaire (PHQ-15)
Hide Description Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.
Time Frame Measured at weeks 0, 8, 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Sample size decreased due to attrition over course of study, N=17 at Week 0, N=12 at Week 8, N=10 at Week 12. Our primary analysis was a repeated measures mixed-methods regression that included all available data points.
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description:

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 Number Analyzed 17 participants
16.06  (3.75)
Week 8 Number Analyzed 12 participants
12.87  (4.26)
Week 12 Number Analyzed 10 participants
11.1  (6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment With Duloxetine
Comments We used the intention-to-treat (ITT) sample with all subjects dispensed medication (n=17). This was a repeated-measures mixed-effects regression analysis assessing the rate of change in PHQ-15 scores of somatization symptoms. To account for the correlation of observations within individuals, we used mixed-effects models with random intercepts and a first-order autocorrelation structure. Data from each time point (weeks 0, 1, 2, 3, 4, 6, 8, 12) were used in the single repeated-measures analysis.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Slope
Estimated Value -4.38
Confidence Interval (2-Sided) 95%
-7.39 to -1.36
Estimation Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description The treating psychiatrist assessed adverse effects systematically at each visit by evaluating 28 potential effects with the Treatment Emergent Side Effect Scale (TESS) on a 4-point Likert scale ranging from 0 (absent) to 3 (severe).
 
Arm/Group Title Treatment With Duloxetine
Hide Arm/Group Description

Patients will receive open treatment with Duloxetine

Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.

All-Cause Mortality
Treatment With Duloxetine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment With Duloxetine
Affected / at Risk (%) # Events
Total   0/17 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment With Duloxetine
Affected / at Risk (%) # Events
Total   6/17 (35.29%)    
Cardiac disorders   
Tachycardia  [1]  1/17 (5.88%)  1
Gastrointestinal disorders   
Nausea and vomiting  [2]  1/17 (5.88%)  1
Constipation  [3]  1/17 (5.88%)  1
General disorders   
Sweating  [4]  1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders   
Neck stiffness  [5]  2/17 (11.76%)  2
Muscle rigidity  [6]  2/17 (11.76%)  2
Indicates events were collected by systematic assessment
[1]
One patient reported tachycardia
[2]
One patient reported nausea and vomiting
[3]
One patient reported constipation
[4]
One patient reported sweating
[5]
Two patients reported neck stiffness
[6]
Two patients reported muscle rigidity
Study limitations include the lack of placebo control, modest sample size, single ethnic group, and high attrition rate.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Roberto Lewis-Fernandez
Organization: New York State Psychiatric Institute
Phone: 646-774-8102
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01754493     History of Changes
Other Study ID Numbers: #6479R
F1J-US-X037 ( Other Grant/Funding Number: Eli Lilly and Company )
First Submitted: December 11, 2012
First Posted: December 21, 2012
Results First Submitted: September 6, 2016
Results First Posted: November 25, 2016
Last Update Posted: November 25, 2016