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
Details
Lead Sponsor:
Stanford University University of California, San Francisco