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

• 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: New York State Psychiatric Institute
• Collaborator: Eli Lilly and Company
• Information provided by (Responsible Party): New York State Psychiatric Institute

Tracking Information

• First Submitted Date: December 11, 2012
• First Posted Date: December 21, 2012
• Results First Submitted Date: September 6, 2016
• Results First Posted Date: November 25, 2016
• Last Update Posted Date: November 25, 2016
• Study Start Date: December 2008
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2016)

• Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Weeks 0, 8, 12 ]
  Clinician-administered 10-item scale measuring depressive symptoms (range 0-60); higher scores indicate greater severity of major depression.
• Gastrointestinal Symptoms Rating Scale (GSRS) [ Time Frame: Weeks 0, 8, 12 ]
  Clinician-administered 15-item scale measuring IBS symptoms (range 15-105); higher score indicates greater IBS severity.

Original Primary Outcome Measures (submitted: December 18, 2012)

• Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Up to week 12 ]
• Gastrointestinal Symptoms Rating Scale (GSRS) [ Time Frame: Up to week 12 ]

Current Secondary Outcome Measures (submitted: November 3, 2016)

• Clinician-Rated Global Impression Scales (CGI) [ Time Frame: Measured at weeks 0, 8, 12 ]
  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).
• Visual Analogue Scales (VAS) [ Time Frame: Measured at weeks 0, 8, 12 ]
  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.
• Somatization Module of the Patient's Health Questionnaire (PHQ-15) [ Time Frame: Measured at weeks 0, 8, 12 ]
  Self-report 15-item scale measuring somatization symptoms (range 0-30); higher score indicates greater severity of somatization symptoms.

Original Secondary Outcome Measures (submitted: December 18, 2012)

• Clinician-Rated Global Impression Scales [ Time Frame: Measured at weeks 0, 1, 2, 3, 4, 6, 8, and 12 ]
• Visual Analogue Scales (VAS) [ Time Frame: Measured at weeks 0, 1, 2, 3, 4, 6, 8, and 12 ]
• Somatization Module of the Patient's Health Questionnaire (PHQ-15) [ Time Frame: Measured at weeks 0, 1, 2, 3, 4, 6, 8, and 12 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression
• Official Title: Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression
• Brief Summary: This study will evaluate the efficacy of duloxetine in reducing depressive symptoms, abdominal pain, and other symptoms of Irritable Bowel Syndrome (IRS) in a population of outpatients with Major Depressive Disorder MDD and clinical symptoms of IBS.

Detailed Description

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. Upon study completion at 12 weeks, they will receive an additional 3 months of free medication treatment at our clinic.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Major Depression
• Irritable Bowel Syndrome

Intervention

Drug: 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.

Other Name: Cymbalta

Study Arms

Experimental: Treatment with Duloxetine

Patients will receive open treatment with Duloxetine

Intervention: Drug: Duloxetine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 23, 2015): 17
• Original Estimated Enrollment (submitted: December 18, 2012): 30
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Meets Diagnostic and Statistical Manual,Fourth Edition (DSM-IV) criteria for major depressive disorder (MDD)
• Meets sufficient Rome III criteria for clinical symptoms of IBS
• Able to give consent
• Fluency in English or Spanish
• Patients ages 50-65 must provide a negative colonoscopy report

Exclusion Criteria:

• Current suicide risk
• History of psychosis, bipolar disorder, or a current diagnosis of Obsessive-Compulsive Disorder (OCD)
• History of alcohol or other substance abuse or dependence in the six months prior to the study
• History of non-response to an adequate trial of duloxetine
• Require concurrent treatment with other psychotropic medication or other psychiatric treatment, except zolpidem for insomnia
• Receive current treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of visit 1 or potential need to use an MAOI during the study or within 5 days of discontinuation of study drug
• Patients with uncontrolled narrow-angle glaucoma
• Received electroconvulsive therapy (ECT) during the last three months
• Unable to tolerate or unwillingness to accept drug-free period of varying length: 1 week for Pro Re Nata (PRN) benzodiazepines; 2 weeks for antidepressants (other than fluoxetine), buspirone, lithium, anticonvulsants, stimulants, barbiturates, opiates, regular-use benzodiazepines (except clonazepam); 5 weeks for clonazepam and fluoxetine
• Clinically unstable medical disease including: Systemic hypertension of 140/90 mm Hg or more; known hypersensitivity to duloxetine or any of its inactive ingredients; liver function test values three times above the normal level; clinically significant thyroid dysfunction, (except patients who are stable on thyroid replacement therapy for at least three months)
• History of chronic, persisting vomiting; rectal bleeding (melena, hematochezia, Bright Red Blood Per Rectum); severe, continuous abdominal pain; nocturnal awakening with GI symptoms; weight loss not clearly related to decreased appetite of MDD; incapacitating symptoms of IBS; severe Upper GI symptoms (e.g., heartburn) that interrupt daily activities
• Family history of Ulcerative Colitis, Crohn's Disease, Celiac Disease or Colon Cancer
• Clinical findings on Physical Exam or laboratory tests of: Rectal bleeding/obstruction, elevated White Blood Cell (WBC) count, unexplained anemia, abnormal Erythrocyte Sedimentation Rate (ESR), abnormal celiac disease panel
• Evidence of clinically significant renal, pulmonary, cerebral vascular, cardiovascular, endocrine disorders, prostatic hypertrophy, urinary retention, laboratory abnormalities, abnormal electrocardiogram
• Cancer of any type. Patients in remission for 5 years or more may be judged acceptable
• Patients with current or past history of seizure disorder (except febrile seizure in childhood)
• Patients who are pregnant, breast-feeding or who do not use adequate contraceptive methods. Adequate methods include birth control pills, condom plus spermicide, an intrauterine device, the Norplant system, or diaphragm.
• Patients who are receiving effective medication for their depression or their IBS symptoms. Patients on effective medication for either disorder will be excluded.
• Patients on antidepressants and/or anti-IBS medications at intake must still meet inclusion criteria after receiving 3 months or more of medication that was dosed following FDA guidelines. Doses must have been raised so as to produce either intolerable side effects or treatment response.
• Patients who require treatment with thioridazine for any reason, at baseline and throughout the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01754493
• Other Study ID Numbers: #6479R; F1J-US-X037 ( Other Grant/Funding Number: Eli Lilly and Company )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: New York State Psychiatric Institute
• Study Sponsor: New York State Psychiatric Institute
• Collaborators: Eli Lilly and Company

Investigators

• Principal Investigator: Roberto Lewis-Fernandez, M.D.; New York State Psychiatric Institute

• PRS Account: New York State Psychiatric Institute
• Verification Date: December 2012