Citalopram in Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT00477165

Run by

Stanford University

People needed

54

Starts

2001-04-01

Expected to finish

2009-06-01

Last updated by the study team

2017-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion criteria are:
• Fulfilling Rome II IBS definition;
• Age ≥18 yrs and able to give informed consent;
• 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.

You may not qualify if…

• Exclusion criteria are:
• Current psychiatric diagnosis or active treatment with antidepressants;
• Pregnancy;
• Major systemic illness, or illness that could explain IBS-like symptoms;
• Active IBS therapy other than fiber or loperamide.

Where it is running

• UCSF — San Francisco, California, United States

Full record on ClinicalTrials.gov

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