Treatment of Functional Bowel Disorders

• Status: Completed
• Trial end date: 2001-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Desipramine

Criteria

Inclusion Criteria:

• Literate, female patients aged 18-65.

• Symptoms present at least 2 days/week for greater than 6 months.

• Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria.

• Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110.

• Discontinuation of all antidepressant medications for at least 3 months.

• Use of acceptable method of birth control.

Exclusion Criteria:

• Evidence of lactose intolerance to explain bowel symptoms.

• Heart disease.

• Cardiac arrhythmias.

• Severe psychiatric disorder (e.g., bipolar, suicide attempts).

• Previous use of desipramine.

• Glaucoma.

• Urinary retention.

• Pregnancy.

• Alcohol consumption 3oz/day that would preclude participation or prevent data assessment.

• Systemic gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology.

• Bipolar disorder.

• Schizophrenia.

• Substance abuse/dependency.

• Previous use of desipramine.