Irritable Bowel SyndromePhase 2NCT00477165
Citalopram in Irritable Bowel Syndrome
A Phase 2 study testing Citalopram in people with Irritable Bowel Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Citalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Citalopram, Placebo
- Keywords
- Irritable bowel syndrome, Antidepressant, IBS, Serotonin-reuptake inhibitor, SSRI, Visceral sensitivity, Barostat, Quality of life, Depression
- Medical subject headings
- Irritable Bowel Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
Also called Celexa, Cipramil
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
| Study group | Role | What they receive |
|---|---|---|
| Citalopram | Experimental | One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks Receives: Drug: Citalopram |
| Placebo | Placebo comparator | Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Participants Who Self-reported "Adequate Relief"
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.
Measured: Baseline, weekly for 8 weeks
Secondary outcomes (3)
Change From Baseline in IBS-QOL Score at 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.
Measured: Baseline; Week 8
Mean Sensation Score as a Function of Distending Pressure at the End of the Study
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.
Measured: Week 8
Urgency Score as a Function of Distending Pressure at the End of the Study
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startApr 2001
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Uri Ladabaum, University of California, San Francisco
- Investigators
- Uri Ladabaum, M.D., M.S., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477165
- Sponsor's protocol ID
- H10539-18502
- Status last verified
- Mar 2017
- First submitted
- 18 May 2007
- Last updated
- 17 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Citalopram on Clinical Symptoms and Visceral Sensitivity in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00477165
- Acronym / sponsor ID
- H10539-18502
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Antidepressant, IBS, Serotonin-reuptake inhibitor, SSRI, Visceral sensitivity, Barostat, Quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citalopram | Experimental | Drug: CitalopramOne 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboIdentical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitalopramAlso: Celexa, Cipramil20mg/day for 4 weeks, then 40 mg/day for 4 weeks | Drug | Citalopram |
| PlaceboIdentical to citalopram 20mg capsules; 1 capsule/day for 4 weeks, then 2 capsules/day for 4 weeks | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Change From Baseline in IBS-QOL Score at Week 8
Time frame: Baseline; Week 8
Mean Sensation Score as a Function of Distending Pressure at the End of the Study
Time frame: Week 8
Urgency Score as a Function of Distending Pressure at the End of the Study
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uri Ladabaum, M.D., M.S. principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Citalopram in people with Irritable Bowel Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Participants Who Self-reported "Adequate Relief" (time frame: Baseline, weekly for 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2017.