Citalopram in Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypotheses:

1. Primary null hypothesis: The rate of clinical response, assessed as patient-reported global symptom rating and "adequate relief of IBS symptoms," does not differ between non-depressed IBS patients treated with the SSRI citalopram and patients treated with placebo.

2. Secondary null hypotheses:

1. Changes in disease-related quality of life, assessed with the IBS-QOL instrument, do not differ between patients treated with the SSRI citalopram and patients treated with placebo.

2. Changes in rectosigmoid visceral sensitivity, assessed by barostat balloon distention, do not differ between patients treated with the SSRI citalopram and patients treated with placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University; University of California, San Francisco
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

Inclusion criteria are:

1. Fulfilling Rome II IBS definition;

2. Age ≥18 yrs and able to give informed consent;

3. Normal sigmoidoscopy, colonoscopy or barium enema within 5 years, normal complete blood count and thyroid studies, and negative stool ova and parasite exam for patients with diarrhea.

Exclusion Criteria:

Exclusion criteria are:

1. Current psychiatric diagnosis or active treatment with antidepressants;

2. Pregnancy;

3. Major systemic illness, or illness that could explain IBS-like symptoms;

4. Active IBS therapy other than fiber or loperamide.