CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
Citalopram +1 moredrug
Likely dose
Citalopram 20mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00477165
NCT00477165Phase 2Completed
CompareCT.gov

Effect of Citalopram on Clinical Symptoms and Visceral Sensitivity in Patients With Irritable Bowel Syndrome

Stanford University·interventional·Posted May 22, 2007·Updated Apr 17, 2017

In Brief

A Phase 2 clinical trial evaluating Citalopram and Placebo for Irritable Bowel Syndrome. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 22, 2007
Enrollment StartApr 1, 2001
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 19.1 years ago

Interventions

Citalopramdrug

20mg/day for 4 weeks, then 40 mg/day for 4 weeks

Placebodrug

Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks