drugset / Trial / NCT00006157

Treatment of Functional Bowel Disorders

NCT00006157

RandomizedDouble-blindTreatment

Summary

The primary purpose for this study is to compare clinical treatments for patients with functional bowel disorders (irritable bowel syndrome, abdominal pain, painful constipation) in women. We also plan to: 1) determine what clinical features (medical or psychological) determine which patients will improve to these treatments, and 2) understand if there are any physiological features that relate to improvement in symptoms and response to the treatments. We will compare a psychological treatment (cognitive-behavioral therapy - CBT) with education/attention placebo, and an antidepressant drug (desipramine) with a pill placebo. This is the first large-scale study designed to determine the therapeutic effects of these methods, and to also determine interactions among physiologic measures, psychologic and sociodemographic factors, severity of symptoms, and therapeutic improvement including quality of life.

Timeline

Start
1996-07
Primary completion
Completion
2001-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Desipramine Small molecule