Trial Outcomes & Findings for Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression (NCT NCT01754493)
NCT ID: NCT01754493
Last Updated: 2021-05-19
Results Overview
Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.
COMPLETED
PHASE4
17 participants
Weeks 0, 8, 12
2021-05-19
Participant Flow
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.
This study was a single-arm open trial, so all the participants were assigned to the open-label duloxetine treatment arm.
Participant milestones
| Measure |
Treatment With Duloxetine
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.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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7
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Reasons for withdrawal
| Measure |
Treatment With Duloxetine
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.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lost to Follow-up
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3
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Moved out of town
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1
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Overall Study
Scheduling conflict
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1
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Baseline Characteristics
Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression
Baseline characteristics by cohort
| Measure |
Treatment With Duloxetine
n=17 Participants
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.
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|---|---|
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Age, Continuous
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42.7 years
STANDARD_DEVIATION 11.0 • n=5 Participants
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
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4 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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17 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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17 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Weeks 0, 8, 12Population: 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.
Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.
Outcome measures
| Measure |
Treatment With Duloxetine
n=17 Participants
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.
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|---|---|
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Montgomery-Asberg Depression Rating Scale (MADRS)
Week 0
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31.59 units on a scale
Standard Deviation 8.46
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Montgomery-Asberg Depression Rating Scale (MADRS)
Week 8
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15.67 units on a scale
Standard Deviation 11.39
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Montgomery-Asberg Depression Rating Scale (MADRS)
Week 12
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11.4 units on a scale
Standard Deviation 6.7
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PRIMARY outcome
Timeframe: Weeks 0, 8, 12Population: 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.
Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.
Outcome measures
| Measure |
Treatment With Duloxetine
n=17 Participants
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.
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|---|---|
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Gastrointestinal Symptoms Rating Scale (GSRS)
Week 0
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54.76 units on a scale
Standard Deviation 15.45
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Gastrointestinal Symptoms Rating Scale (GSRS)
Week 8
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36.33 units on a scale
Standard Deviation 13.93
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Gastrointestinal Symptoms Rating Scale (GSRS)
Week 12
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31.4 units on a scale
Standard Deviation 12.27
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SECONDARY outcome
Timeframe: Measured at weeks 0, 8, 12Population: 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.
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).
Outcome measures
| Measure |
Treatment With Duloxetine
n=17 Participants
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.
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|---|---|
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Clinician-Rated Global Impression Scales (CGI)
CGI - IBS, Week 0
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4.65 units on a scale
Standard Deviation 0.70
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Clinician-Rated Global Impression Scales (CGI)
CGI - IBS, Week 8
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3.58 units on a scale
Standard Deviation 0.67
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Clinician-Rated Global Impression Scales (CGI)
CGI - IBS, Week 12
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3 units on a scale
Standard Deviation 0.94
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Clinician-Rated Global Impression Scales (CGI)
CGI - Major Depression, Week 0
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4.71 units on a scale
Standard Deviation 0.85
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Clinician-Rated Global Impression Scales (CGI)
CGI - Major Depression, Week 8
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3.58 units on a scale
Standard Deviation 0.67
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Clinician-Rated Global Impression Scales (CGI)
CGI - Major Depression, Week 12
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3 units on a scale
Standard Deviation 0.94
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SECONDARY outcome
Timeframe: Measured at weeks 0, 8, 12Population: 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.
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.
Outcome measures
| Measure |
Treatment With Duloxetine
n=17 Participants
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.
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|---|---|
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Visual Analogue Scales (VAS)
Overall pain, Week 0
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5 units on a scale
Standard Deviation 2.62
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Visual Analogue Scales (VAS)
Pain interfering with daily activities, Week 0
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4.94 units on a scale
Standard Deviation 3.42
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Visual Analogue Scales (VAS)
Headaches, Week 0
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4.24 units on a scale
Standard Deviation 2.19
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Visual Analogue Scales (VAS)
Back pain, Week 0
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5.47 units on a scale
Standard Deviation 2.62
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Visual Analogue Scales (VAS)
Shoulder pain, Week 0
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5.29 units on a scale
Standard Deviation 3.21
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Visual Analogue Scales (VAS)
Overall pain, Week 8
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6.08 units on a scale
Standard Deviation 2.11
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Visual Analogue Scales (VAS)
Pain interfering with daily activities, Week 8
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6 units on a scale
Standard Deviation 2.70
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Visual Analogue Scales (VAS)
Headaches, Week 8
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4.5 units on a scale
Standard Deviation 2.97
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Visual Analogue Scales (VAS)
Back pain, Week 8
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5.58 units on a scale
Standard Deviation 3
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Visual Analogue Scales (VAS)
Shoulder pain, Week 8
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5.17 units on a scale
Standard Deviation 3.07
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Visual Analogue Scales (VAS)
Overall pain, Week 12
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4.1 units on a scale
Standard Deviation 3
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Visual Analogue Scales (VAS)
Pain interfering with daily activities, Week 12
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4.8 units on a scale
Standard Deviation 3.01
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Visual Analogue Scales (VAS)
Headaches, Week 12
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3.4 units on a scale
Standard Deviation 2.63
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Visual Analogue Scales (VAS)
Back pain, Week 12
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4.9 units on a scale
Standard Deviation 3.03
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Visual Analogue Scales (VAS)
Shoulder pain, Week 12
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4.7 units on a scale
Standard Deviation 3.3
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SECONDARY outcome
Timeframe: Measured at weeks 0, 8, 12Population: 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.
Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.
Outcome measures
| Measure |
Treatment With Duloxetine
n=17 Participants
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.
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|---|---|
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Somatization Module of the Patient's Health Questionnaire (PHQ-15)
Week 0
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16.06 units on a scale
Standard Deviation 3.75
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Somatization Module of the Patient's Health Questionnaire (PHQ-15)
Week 8
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12.87 units on a scale
Standard Deviation 4.26
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Somatization Module of the Patient's Health Questionnaire (PHQ-15)
Week 12
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11.1 units on a scale
Standard Deviation 6
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Adverse Events
Treatment With Duloxetine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment With Duloxetine
n=17 participants at risk
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.
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|---|---|
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Musculoskeletal and connective tissue disorders
Neck stiffness
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11.8%
2/17 • Number of events 2 • 12 weeks
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).
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Musculoskeletal and connective tissue disorders
Muscle rigidity
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11.8%
2/17 • Number of events 2 • 12 weeks
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).
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Gastrointestinal disorders
Nausea and vomiting
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5.9%
1/17 • Number of events 1 • 12 weeks
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).
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Gastrointestinal disorders
Constipation
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5.9%
1/17 • Number of events 1 • 12 weeks
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).
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General disorders
Sweating
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5.9%
1/17 • Number of events 1 • 12 weeks
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).
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Cardiac disorders
Tachycardia
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5.9%
1/17 • Number of events 1 • 12 weeks
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).
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Additional Information
Roberto Lewis-Fernandez
New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place