- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00477165
Citalopram in Irritable Bowel Syndrome
March 2, 2017 updated by: Uri Ladabaum, Stanford University
Effect of Citalopram on Clinical Symptoms and Visceral Sensitivity in Patients With Irritable Bowel Syndrome
Hypotheses:
- 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.
Secondary null hypotheses:
- 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.
- 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 Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Irritable bowel syndrome (IBS) affects an estimated 15 million Americans at a cost of $1.7 billion per year.
Visceral hypersensitivity is present in many patients with IBS, but its contribution to clinical symptoms is unclear.
Tricyclic antidepressants may be beneficial in IBS, but their side effects can be unacceptable.
Because they are better tolerated, selective serotonin reuptake inhibitors (SSRIs) are often used to treat IBS, but their efficacy in IBS has not been examined in controlled studies.
We propose a randomized, placebo-controlled trial of SSRI treatment in IBS.
Non-depressed patients will be studied in order to assess SSRI effects on IBS independent of depression.
Our specific aims are: 1) To determine whether the SSRI citalopram is superior to placebo in improving clinical symptoms, disease-related quality of life, and tolerance to rectal balloon distension; 2) To assess whether symptomatic improvement is correlated with improvement in quality of life and/or visceral sensitivity.
Subjects will fulfill Rome II IBS criteria, will have normal screening studies, and will not be depressed or on antidepressants.
Global and specific symptoms, and satisfaction will be rated daily during a 1-week baseline.
Subjects will then be randomized in concealed, double-blind fashion to citalopram or placebo, will complete the validated IBS-QOL instrument, and will undergo rectal compliance and sensory testing with a barostat.
Subjects will be treated and will rate symptoms and satisfaction weekly for a total of 8 weeks, and also daily during the final week for comparison with the baseline.
At study end, subjects will again complete the IBS-QOL and undergo a barostat study.
For the primary outcome, we estimate that to detect a standardized effect size of 0.9 in global symptom rating with 2-sided α=0.05 and β=0.1, 54 subjects are needed.
We plan to enroll 60 subjects, which will allow detection of an odds ratio for response (adequate relief) of 4.5 with 2-sided α=0.05 and β=0.2.
If the odds ratio for this dichotomous outcome is smaller, this study will provide pilot data for a larger trial.
Clinical symptoms are expected to fluctuate.
Even if citalopram is not superior to placebo, prospectively collected data will illuminate the relationship between symptoms and visceral sensitivity, and the placebo effect.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- UCSF
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Citalopram
One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
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20mg/day for 4 weeks, then 40 mg/day for 4 weeks
Other Names:
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Placebo Comparator: Placebo
Identical to citalopram 20mg capsule.
One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
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Identical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Count of Participants Who Self-reported "Adequate Relief"
Time Frame: Baseline, weekly for 8 weeks
|
Participants were asked weekly to answer subjectively whether weekly adequate relief from IBS symptoms was achieved.
Overall response was defined as having achieved adequate relief in at least 3 of the past 6 weeks.
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Baseline, weekly for 8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in IBS-QOL Score at Week 8
Time Frame: Baseline; Week 8
|
The IBS-QOL is a self-report quality-of-life measure specific to Irritable Bowel Syndrome (IBS) that can be used to assess the impact of IBS and its treatment.
The IBS-QOL consists of 34 statements about bowel problems, each with a five-point response scale ranging from 1 (no problems) to 5 (most problems).
The individual scores are summed and averaged for a total score, then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life.
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Baseline; Week 8
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Mean Sensation Score as a Function of Distending Pressure at the End of the Study
Time Frame: Week 8
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A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second.
After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated sensation 30 seconds into each inflation.
Sensation score scale: 0=no inflation sensation, 1-5=increasing painless sensation, 6=threshold pain, 10=worst imaginable pain.
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Week 8
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Urgency Score as a Function of Distending Pressure at the End of the Study
Time Frame: Week 8
|
A 500mL polyethylene bag was passed into the rectum, with tubing connected to a barostat, which was controlled by a computer that recorded bag pressure, volume, and corrected volume every second.
After 5 minutes, the bag was unfurled with 100mL of air and deflated; with inflations lasting 45 seconds from 0 up to 60 mmHg, increasing by 3 mmHg, and separated by 45-second deflations, subjects rated urgency for bowel movement 30 seconds into each inflation.
Urgency score scale: 0=no urgency, 1=threshold urgency, 5=worst imaginable urgency.
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Week 8
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Uri Ladabaum, M.D., M.S., University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 18, 2007
First Submitted That Met QC Criteria
May 21, 2007
First Posted (Estimate)
May 22, 2007
Study Record Updates
Last Update Posted (Actual)
April 17, 2017
Last Update Submitted That Met QC Criteria
March 2, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Antidepressive Agents, Second-Generation
- Citalopram
Other Study ID Numbers
- H10539-18502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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