Open Trial of Duloxetine in Outpatients With Irritable Bowel Syndrome Symptoms and Co-Morbid Major Depression
Condition: Major Depression; Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Duloxetine
Intervention 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.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depression; Irritable Bowel Syndrome; Somatization; Cymbalta; Duloxetine

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.
    

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.