Citalopram in Irritable Bowel Syndrome

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.

Timeline

Start

2001-04

Primary completion

2009-06

Completion

2009-06

Outcome

Missed primary endpoint

registry Citalopram vs Placebo; p = 0.59; Odds Ratio (OR) 0.91 (95% CI 0.687 to 1.196) NCT00477165 ↗

Drugs

Indications