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Trial record 63 of 590 for:    ESCITALOPRAM AND Celexa

Citalopram in Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00477165
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Uri Ladabaum, University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Irritable Bowel Syndrome
Interventions Drug: Citalopram
Drug: Placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details A total of 234 potentially eligible subjects were identified. Of these, 180 were excluded and 54 enrolled in the study, with 27 each randomized to citalopram and placebo.
Arm/Group Title Cialopram Placebo
Hide Arm/Group Description One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Period Title: Overall Study
Started 27 27
Completed 20 25
Not Completed 7 2
Reason Not Completed
Adverse Event             7             2
Arm/Group Title Cialopram Placebo Total
Hide Arm/Group Description One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 27 27 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 27 participants 54 participants
53
(27 to 75)
51
(30 to 75)
52
(27 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 27 participants 54 participants
Female
21
  77.8%
23
  85.2%
44
  81.5%
Male
6
  22.2%
4
  14.8%
10
  18.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 27 participants 54 participants
27 27 54
1.Primary Outcome
Title Count of Participants Who Self-reported "Adequate Relief"
Hide Description 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.
Time Frame Baseline, weekly for 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Overall Number of Participants Analyzed 27 27
Measure Type: Count of Participants
Unit of Measure: Participants
12
  44.4%
15
  55.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Null hypothesis: number of patients achieving adequate relief is the same in both Citalopram and Placebo groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments p<0.05 for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.687 to 1.196
Estimation Comments Repeated-measures logistic regression model, assuming the citalopram effect builds linearly over time starting at week 3.
2.Secondary Outcome
Title Change From Baseline in IBS-QOL Score at Week 8
Hide Description 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.
Time Frame Baseline; Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Overall Number of Participants Analyzed 27 27
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
6.3
(-0.07 to 12.7)
7.6
(2.4 to 12.9)
3.Secondary Outcome
Title Mean Sensation Score as a Function of Distending Pressure at the End of the Study
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Overall Number of Participants Analyzed 20 25
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Distending pressure 12mmHg
1
(1 to 2)
2
(2 to 3)
Distending pressure 24mmHg
4
(3 to 5)
6
(3 to 6)
Distending pressure 36mmHg
5
(4 to 7)
7
(5 to 9)
Distending pressure 48mmHg
7
(5 to 8)
6
(4 to 10)
4.Secondary Outcome
Title Urgency Score as a Function of Distending Pressure at the End of the Study
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data were included in the analysis.
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks
Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
Overall Number of Participants Analyzed 20 25
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Distending pressure 12mmHg
1
(1 to 2)
2
(1 to 2)
Distending pressure 24mmHg
4
(3 to 4)
5
(4 to 5)
Distending pressure 36mmHg
4
(4 to 5)
5
(4 to 5)
Distending pressure 48mmHg
5
(4 to 5)
5
(4 to 5)
Time Frame 8 weeks
Adverse Event Reporting Description During the study, subjects were asked to call a research coordinator weekly to report completion of questionnaires. If the telephone call was not received, a research coordinator contacted the subject. Subjects were asked to call if they experienced side effects.
 
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description One 20mg capsule per day for 4 weeks, then 2 capsules per day (40mg) for 4 weeks Identical to citalopram 20mg capsule. One capsule per day for 4 weeks, then 2 capsules per day for 4 weeks
All-Cause Mortality
Citalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/27 (25.93%)      2/27 (7.41%)    
Gastrointestinal disorders     
Diarrhea *  1/27 (3.70%)  1 0/27 (0.00%)  0
Abdominal pain *  1/27 (3.70%)  1 0/27 (0.00%)  0
General disorders     
Fatigue * [1]  3/27 (11.11%)  3 0/27 (0.00%)  0
Insomnia *  1/27 (3.70%)  2 0/27 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Pregnancy * [2]  0/27 (0.00%)  0 1/27 (3.70%)  1
Psychiatric disorders     
Somnolence *  0/27 (0.00%)  0 1/27 (3.70%)  1
Reproductive system and breast disorders     
Sexual dysfunction *  1/27 (3.70%)  1 0/27 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
decreased energy
[2]
pregnancy despite birth control
Results have been entered as available in the published manuscript; the PI is no longer at UCSF. This trial has the limitation of relatively small sample size. A potential limitation is that patients could have been unblinded based on side effects.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Uri Ladabaum, MD, MS
Organization: Stanford University
EMail: ladabau@stanford.edu
Layout table for additonal information
Responsible Party: Uri Ladabaum, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00477165     History of Changes
Other Study ID Numbers: H10539-18502
First Submitted: May 18, 2007
First Posted: May 22, 2007
Results First Submitted: April 10, 2015
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017