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 |
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Recruitment Status :
Completed
First Posted : December 21, 2012
Results First Posted : November 25, 2016
Last Update Posted : November 25, 2016
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: N/A; 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 |
|---|---|
 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 | |
|---|---|---|
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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. |
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| Overall Number of Baseline Participants | 17 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 17 participants | |
| 42.7 (11.0) | ||
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Gender
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | |
| Female |
13 76.5%
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| Male |
4 23.5%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 17 participants | |
| Hispanic or Latino |
17 100.0%
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| Not Hispanic or Latino |
0 0.0%
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| Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 17 participants |
| 17 | ||
| Name/Title: | Roberto Lewis-Fernandez |
| Organization: | New York State Psychiatric Institute |
| Phone: | 646-774-8102 |
| EMail: | rlewis@nyspi.columbia.edu |
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01754493 |
| 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 |