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.
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.