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 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 …