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

Inclusion Criteria:

• Meets Diagnostic and Statistical Manual,Fourth Edition (DSM-IV) criteria for majordepressive 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-CompulsiveDisorder (OCD)
• History of alcohol or other substance abuse or dependence in the six months prior tothe study
• History of non-response to an adequate trial of duloxetine
• Require concurrent treatment with other psychotropic medication or other psychiatrictreatment, except zolpidem for insomnia
• Receive current treatment with a monoamine oxidase inhibitor (MAOI) within 14 days ofvisit 1 or potential need to use an MAOI during the study or within 5 days ofdiscontinuation 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: 1week for Pro Re Nata (PRN) benzodiazepines; 2 weeks for antidepressants (other thanfluoxetine), 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 Hgor more; known hypersensitivity to duloxetine or any of its inactive ingredients;liver function test values three times above the normal level; clinically significantthyroid dysfunction, (except patients who are stable on thyroid replacement therapyfor at least three months)
• History of chronic, persisting vomiting; rectal bleeding (melena, hematochezia, BrightRed Blood Per Rectum); severe, continuous abdominal pain; nocturnal awakening with GIsymptoms; weight loss not clearly related to decreased appetite of MDD; incapacitatingsymptoms of IBS; severe Upper GI symptoms (e.g., heartburn) that interrupt dailyactivities
• Family history of Ulcerative Colitis, Crohn's Disease, Celiac Disease or Colon Cancer
• Clinical findings on Physical Exam or laboratory tests of: Rectalbleeding/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 inchildhood)
• Patients who are pregnant, breast-feeding or who do not use adequate contraceptivemethods. Adequate methods include birth control pills, condom plus spermicide, anintrauterine device, the Norplant system, or diaphragm.
• Patients who are receiving effective medication for their depression or their IBSsymptoms. Patients on effective medication for either disorder will be excluded.
• Patients on antidepressants and/or anti-IBS medications at intake must still meetinclusion criteria after receiving 3 months or more of medication that was dosedfollowing FDA guidelines. Doses must have been raised so as to produce eitherintolerable side effects or treatment response.
• Patients who require treatment with thioridazine for any reason, at baseline andthroughout the study.