Depressive DisorderPhase 4NCT01916200
Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients
A Phase 4 study testing Paroxetine CR in people with Depressive Disorder, run by GlaxoSmithKline.
Trial summary
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Paroxetine CR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Sep 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic for IBS according to ROME III;
- Meet the diagnostic for MDD according to MINI;
- Age≥18 and ≤ 65;
- Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation; processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
Who cannot join
- Patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine CR [Seroxat CR®];
- History of alcohol / drug dependence and schizophrenia; history of serious mental illness;
- Major neurological deficits that interfere with the patient's ability to understand the study procedures and provide a written informed consent;
- Patients were also excluded if their current episode of depression had failed to respond to two or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks;
- Suicide ideation;
- Use monoamine oxidase inhibitors (MAOIs), benzodiazepines or other antidepressants within at least 14 days before study begin;
Show all 14Show fewer
- Other medical and psychological conditions prevent patients from participating in the study or signing informed consent;
- Pregnant or lactating females, or anyone who plan to become pregnant during the study period;
- Those who are known to currently participate a clinical trial;
- Those patients with significant organ disease. GI disorders that are infectious;
- Ischemic, radiation-induced, or medication-induced; inflammatory bowel disease (Cohn's disease and ulcerative colitis);
- Recent gastrointestinal surgery (within 6 months).
- Has received electroconvulsive therapy (ECT) or psychotherapy in the 3 months prior to screening.
- Presents with clinically significant abnormalities in haematology, clinical chemistry, electrocardiogram (ECG) or physical examination at screening which have not resolved prior to the baseline visit or has clinically significant conditions, which in the opinion of the investigator, will render the patient unsuitable for the study and pose a safety concern or interfere with the accurate safety and efficacy assessments (e.g., severe cardiovascular disease, hepatic or renal failure etc).
About this study
Official title: Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients: An Open-label, Randomized, add-on Study
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS).
Subjects will be patients who are referred to the outpatient or inpatient clinic of gastroenterology departments of province level general hospitals in China. All subjects present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written informed consent prior to participating in the study. Subjects will be assessed for eligibility at a screening visit, with eligible patients returning for a assessment within 1 week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose: 12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study treatment visits.
Read the detailed description
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine CR in patients with MDD comorbid IBS.
This study is designed with a 1-week screening period, followed by 8 weeks of treatment and 1 week follow up period, 7 visits totally; the calculation of visit date is base on the real date of random date.
Study Screening:
Visit 1: a screening period for within 7 days to determine eligibility for the study, subjects aged ≥ 18 and ≤ 65 years at the time of screening, must have a diagnosis of IBS and MDD. After giving their informed consent to participate in the study, patients will undergo screening assessments, including demographic data (birth, race, gender, height, weight), medical history, disease history, therapy history, concomitant medication, physical examination, vital signs, 12-lead ECG and laboratory assessments.
Treatment Phase:
The treatment phase will last for 8 weeks. The visit (except baseline) will have ±3 days.
Visit 2 (Day 0, baseline visit): Patients who fulfil all the study inclusion and exclusion criteria will accept baseline assessment (including concomitant medication, vital signs and scale assessment) and be randomised into paroxetine CR plus IBS regular treatment group or IBS regular treatment only group at baseline visit. The day after randomizing (Day 1), patients will receive paroxetine CR 12.5mg/d plus IBS regular treatment or IBS regular treatment only (patients who have received IBS regular treatment before can continue their treatment). On Day 8, following 1 weeks of treatment, paroxetine CR should be titrated to 25mg/d.
Visit 3-5 (Day 14, Day 28, Day 42): Efficacy and safety assessments will be performed at these visits, including vital signs and HDRS-17 (Hamilton Depression Rating Scale 17 items), CGI-S (Clinical Global Impression- Severity), CGI-I (Clinical Global Impression- Improvement), WHOQOL (World Health Organization Quality of Life Assessment), IBSSS (The Irritable Bowel Severity Scoring System). From Week 3 to 6, the investigator can titrate the subject's dose upwards according to clinical response and tolerability, at a maximum rate of paroxetine CR 12.5mg every 14 days. For example, if CGI-I is ≥3 based on the assessment at scheduled clinic visit, and the patient is able to tolerate an increased dose, the dose increment to the next dose level shall be considered. The highest dose that may be administered is paroxetine CR 50 mg and dose titration may only occur at scheduled visits.
Visit 6 (Day 56): Efficacy and safety assessments will be performed at these visits, including vital signs, physical examination, laboratory assessments and HDRS-17, CGI-S, CGI-I, WHOQOL, IBSSS.
If the patient experiences an adverse event (AE) and the investigator deems that a reduction in dose is required then the patient may be administered a dose one level (paroxetine CR 12.5 mg) lower than they were taking previously. Upon resolution of the AE, the investigator may return to patient's pre-AE dose level.
Follow-Up:
After treatment phase, the investigator should communicate with all the subjects about the follow-up choice: reduce or continuing paroxetine CR treatment/ other antidepressants treatment/ transferring to psychiatric clinics. It is not recommend to reduce drug dosage during the treatment period of MDD.
For those subjects who decide to discontinue paroxetine CR treatment: a gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. The dosage should be reduced weekly, the daily dose reduction is 12.5mg per week, and once a week. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Visit 7 (Day 63): the investigator should conduct safety follow up by phone call to all participants to investigate the medication situation and safety related information.
Withdraw:
Patients withdrawn from the study prior to Visit 6 (Week 8) will have all end-of-study procedures performed. Patients withdrawn from the study for any reason are to attend an early withdrawal visit on withdrawal from the study. In addition, patients have to taper the study drug if they end the study on a dose level higher than dose level 1 (paroxetine CR 12.5 mg). The dosage should be reduced weekly, the daily dose reduction is 12.5mg per week, and once a week.
- Conditions
- Depressive Disorder
- Being tested
- Paroxetine CR
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine CRDrug
Paroxetine CR will be provided by GlaxoSmithKline (GSK) and be available as 12.5 mg over-encapsulated tablets with the research use only label outside the package. Paroxetine CR should be administered as a single daily dose, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of paroxetine CR in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5 mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Paroxetine CR group | Experimental | Paroxetine CR plus IBS regular treatment group Receives: Drug: Paroxetine CR |
| Blank group | No intervention | IBS regular treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-17
Measured: 8 weeks
Secondary outcomes (5)
HDRS-17 item 10
Measured: 8 weeks
CGI-I
Measured: 8 weeks
CGI-S
Measured: 8 weeks
WHOQOL
Measured: 8 weeks
IBSSS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Why it stopped: This study was Cancelled Before Active
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916200
- Sponsor's protocol ID
- 117049
- Status last verified
- Jul 2014
- First submitted
- 1 Aug 2013
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
PubMed 14645642Creed F, Fernandes L, Guthrie E, Palmer S, Ratcliffe J, Read N, Rigby C, Thompson D, Tomenson B; North of England IBS Research Group. The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndrome. Gastroenterology. 2003 Feb;124(2):303-17. doi: 10.1053/gast.2003.50055.
PubMed 12557136Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
PubMed 9146781Cho HS, Park JM, Lim CH, Cho YK, Lee IS, Kim SW, Choi MG, Chung IS, Chung YK. Anxiety, depression and quality of life in patients with irritable bowel syndrome. Gut Liver. 2011 Mar;5(1):29-36. doi: 10.5009/gnl.2011.5.1.29. Epub 2011 Mar 16.
PubMed 21461069Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, Whitehead WE, Janssens J, Funch-Jensen P, Corazziari E, et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig Dis Sci. 1993 Sep;38(9):1569-80. doi: 10.1007/BF01303162.
PubMed 8359066Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
PubMed 16678561Russo MW, Gaynes BN, Drossman DA. A national survey of practice patterns of gastroenterologists with comparison to the past two decades. J Clin Gastroenterol. 1999 Dec;29(4):339-43. doi: 10.1097/00004836-199912000-00009.
PubMed 10599638Gros DF, Antony MM, McCabe RE, Swinson RP. Frequency and severity of the symptoms of irritable bowel syndrome across the anxiety disorders and depression. J Anxiety Disord. 2009 Mar;23(2):290-6. doi: 10.1016/j.janxdis.2008.08.004. Epub 2008 Aug 27.
PubMed 18819774Sandler RS. Epidemiology of irritable bowel syndrome in the United States. Gastroenterology. 1990 Aug;99(2):409-15. doi: 10.1016/0016-5085(90)91023-y.
PubMed 2365191Boyce PM, Talley NJ, Balaam B, Koloski NA, Truman G. A randomized controlled trial of cognitive behavior therapy, relaxation training, and routine clinical care for the irritable bowel syndrome. Am J Gastroenterol. 2003 Oct;98(10):2209-18. doi: 10.1111/j.1572-0241.2003.07716.x.
PubMed 14572570Guthrie E, Creed F, Fernandes L, Ratcliffe J, Van Der Jagt J, Martin J, Howlett S, Read N, Barlow J, Thompson D, Tomenson B. Cluster analysis of symptoms and health seeking behaviour differentiates subgroups of patients with severe irritable bowel syndrome. Gut. 2003 Nov;52(11):1616-22. doi: 10.1136/gut.52.11.1616.
PubMed 14570732Masand PS, Kaplan DS, Gupta S, Bhandary AN, Nasra GS, Kline MD, Margo KL. Major depression and irritable bowel syndrome: is there a relationship? J Clin Psychiatry. 1995 Aug;56(8):363-7.
PubMed 7635853Vandvik PO, Lydersen S, Farup PG. Prevalence, comorbidity and impact of irritable bowel syndrome in Norway. Scand J Gastroenterol. 2006 Jun;41(6):650-6. doi: 10.1080/00365520500442542.
PubMed 16716962Park JM, Choi MG, Cho YK, Lee IS, Kim JI, Kim SW, Chung IS. Functional Gastrointestinal Disorders Diagnosed by Rome III Questionnaire in Korea. J Neurogastroenterol Motil. 2011 Jul;17(3):279-86. doi: 10.5056/jnm.2011.17.3.279. Epub 2011 Jul 13.
PubMed 21860820Cremonini F, Talley NJ. Irritable bowel syndrome: epidemiology, natural history, health care seeking and emerging risk factors. Gastroenterol Clin North Am. 2005 Jun;34(2):189-204. doi: 10.1016/j.gtc.2005.02.008.
PubMed 15862929
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients: An Open-label, Randomized, add-on Study
- ClinicalTrials.gov ID
- NCT01916200
- Acronym / sponsor ID
- 117049
- Conditions
- Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was Cancelled Before Active
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine Controlled Release (CR) in patients with Major Depressive Disorder (MDD) comorbid Irritable Bowel Syndrome (IBS).
Subjects will be patients who are referred to the outpatient or inpatient clinic of gastroenterology departments of province level general hospitals in China. All subjects present with irritable bowel syndrome according to ROME III, and also are diagnosed with MDD by Mini-International Neuropsychiatric Interview (MINI). All subjects will provide written informed consent prior to participating in the study. Subjects will be assessed for eligibility at a screening visit, with eligible patients returning for a assessment within 1 week, at which time they will randomly enter into paroxetine CR (12.5mg/d, flexible dose: 12.5-50mg/d) plus IBS regular treatment or IBS regular treatment only. Subjects will be evaluated at weeks 2 (Day 14), 4 (Day 28), 6 (Day 42) and 8 (Day 56), for a total of 5 study treatment visits.
Detailed description
This is an open label, randomized, add-on, 8 weeks multicentre study to evaluate the efficacy and safety of paroxetine CR in patients with MDD comorbid IBS.
This study is designed with a 1-week screening period, followed by 8 weeks of treatment and 1 week follow up period, 7 visits totally; the calculation of visit date is base on the real date of random date.
Study Screening:
Visit 1: a screening period for within 7 days to determine eligibility for the study, subjects aged ≥ 18 and ≤ 65 years at the time of screening, must have a diagnosis of IBS and MDD. After giving their informed consent to participate in the study, patients will undergo screening assessments, including demographic data (birth, race, gender, height, weight), medical history, disease history, therapy history, concomitant medication, physical examination, vital signs, 12-lead ECG and laboratory assessments.
Treatment Phase:
The treatment phase will last for 8 weeks. The visit (except baseline) will have ±3 days.
Visit 2 (Day 0, baseline visit): Patients who fulfil all the study inclusion and exclusion criteria will accept baseline assessment (including concomitant medication, vital signs and scale assessment) and be randomised into paroxetine CR plus IBS regular treatment group or IBS regular treatment only group at baseline visit. The day after randomizing (Day 1), patients will receive paroxetine CR 12.5mg/d plus IBS regular treatment or IBS regular treatment only (patients who have received IBS regular treatment before can continue their treatment). On Day 8, following 1 weeks of treatment, paroxetine CR should be titrated to 25mg/d.
Visit 3-5 (Day 14, Day 28, Day 42): Efficacy and safety assessments will be performed at these visits, including vital signs and HDRS-17 (Hamilton Depression Rating Scale 17 items), CGI-S (Clinical Global Impression- Severity), CGI-I (Clinical Global Impression- Improvement), WHOQOL (World Health Organization Quality of Life Assessment), IBSSS (The Irritable Bowel Severity Scoring System). From Week 3 to 6, the investigator can titrate the subject's dose upwards according to clinical response and tolerability, at a maximum rate of paroxetine CR 12.5mg every 14 days. For example, if CGI-I is ≥3 based on the assessment at scheduled clinic visit, and the patient is able to tolerate an increased dose, the dose increment to the next dose level shall be considered. The highest dose that may be administered is paroxetine CR 50 mg and dose titration may only occur at scheduled visits.
Visit 6 (Day 56): Efficacy and safety assessments will be performed at these visits, including vital signs, physical examination, laboratory assessments and HDRS-17, CGI-S, CGI-I, WHOQOL, IBSSS.
If the patient experiences an adverse event (AE) and the investigator deems that a reduction in dose is required then the patient may be administered a dose one level (paroxetine CR 12.5 mg) lower than they were taking previously. Upon resolution of the AE, the investigator may return to patient's pre-AE dose level.
Follow-Up:
After treatment phase, the investigator should communicate with all the subjects about the follow-up choice: reduce or continuing paroxetine CR treatment/ other antidepressants treatment/ transferring to psychiatric clinics. It is not recommend to reduce drug dosage during the treatment period of MDD.
For those subjects who decide to discontinue paroxetine CR treatment: a gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. The dosage should be reduced weekly, the daily dose reduction is 12.5mg per week, and once a week. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.
Visit 7 (Day 63): the investigator should conduct safety follow up by phone call to all participants to investigate the medication situation and safety related information.
Withdraw:
Patients withdrawn from the study prior to Visit 6 (Week 8) will have all end-of-study procedures performed. Patients withdrawn from the study for any reason are to attend an early withdrawal visit on withdrawal from the study. In addition, patients have to taper the study drug if they end the study on a dose level higher than dose level 1 (paroxetine CR 12.5 mg). The dosage should be reduced weekly, the daily dose reduction is 12.5mg per week, and once a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paroxetine CR group | Experimental | Drug: Paroxetine CRParoxetine CR plus IBS regular treatment group |
| Blank group | No intervention | –IBS regular treatment group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic for IBS according to ROME III;
- Meet the diagnostic for MDD according to MINI;
- Age≥18 and ≤ 65;
- Patients or their guardian have the ability to understand and to provide informed consent to the examination, observation, and evaluation; processes specified in this protocol, and have signed the informed consent from based on a full understanding of the trial.
Key exclusion criteria (14 listed)
- Patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine CR [Seroxat CR®];
- History of alcohol / drug dependence and schizophrenia; history of serious mental illness;
- Major neurological deficits that interfere with the patient's ability to understand the study procedures and provide a written informed consent;
- Patients were also excluded if their current episode of depression had failed to respond to two or more adequate trials of antidepressants, benzodiazepines, or other anxiolytics at a clinically appropriate dose for a minimum of 4 weeks;
- Suicide ideation;
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 |
|---|---|---|
| Paroxetine CRParoxetine CR will be provided by GlaxoSmithKline (GSK) and be available as 12.5 mg over-encapsulated tablets with the research use only label outside the package. Paroxetine CR should be administered as a single daily dose, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of paroxetine CR in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5 mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week. | Drug | Paroxetine CR group |
Primary outcome
HDRS-17
Time frame: 8 weeks
5 secondary outcomes
HDRS-17 item 10
Time frame: 8 weeks
CGI-I
Time frame: 8 weeks
CGI-S
Time frame: 8 weeks
WHOQOL
Time frame: 8 weeks
IBSSS
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
- Background: PubMed 14645642Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. doi: 10.1056/NEJMra035579. No abstract available.
- Background: PubMed 12557136Creed F, Fernandes L, Guthrie E, Palmer S, Ratcliffe J, Read N, Rigby C, Thompson D, Tomenson B; North of England IBS Research Group. The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndrome. Gastroenterology. 2003 Feb;124(2):303-17. doi: 10.1053/gast.2003.50055.
- Background: PubMed 9146781Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
- Background: PubMed 21461069Cho HS, Park JM, Lim CH, Cho YK, Lee IS, Kim SW, Choi MG, Chung IS, Chung YK. Anxiety, depression and quality of life in patients with irritable bowel syndrome. Gut Liver. 2011 Mar;5(1):29-36. doi: 10.5009/gnl.2011.5.1.29. Epub 2011 Mar 16.
- Background: PubMed 8359066Drossman DA, Li Z, Andruzzi E, Temple RD, Talley NJ, Thompson WG, Whitehead WE, Janssens J, Funch-Jensen P, Corazziari E, et al. U.S. householder survey of functional gastrointestinal disorders. Prevalence, sociodemography, and health impact. Dig Dis Sci. 1993 Sep;38(9):1569-80. doi: 10.1007/BF01303162.
- Background: PubMed 16678561Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061.
- Background: PubMed 10599638Russo MW, Gaynes BN, Drossman DA. A national survey of practice patterns of gastroenterologists with comparison to the past two decades. J Clin Gastroenterol. 1999 Dec;29(4):339-43. doi: 10.1097/00004836-199912000-00009.
- Background: PubMed 18819774Gros DF, Antony MM, McCabe RE, Swinson RP. Frequency and severity of the symptoms of irritable bowel syndrome across the anxiety disorders and depression. J Anxiety Disord. 2009 Mar;23(2):290-6. doi: 10.1016/j.janxdis.2008.08.004. Epub 2008 Aug 27.
- Background: PubMed 2365191Sandler RS. Epidemiology of irritable bowel syndrome in the United States. Gastroenterology. 1990 Aug;99(2):409-15. doi: 10.1016/0016-5085(90)91023-y.
- Background: PubMed 14572570Boyce PM, Talley NJ, Balaam B, Koloski NA, Truman G. A randomized controlled trial of cognitive behavior therapy, relaxation training, and routine clinical care for the irritable bowel syndrome. Am J Gastroenterol. 2003 Oct;98(10):2209-18. doi: 10.1111/j.1572-0241.2003.07716.x.
- Background: PubMed 14570732Guthrie E, Creed F, Fernandes L, Ratcliffe J, Van Der Jagt J, Martin J, Howlett S, Read N, Barlow J, Thompson D, Tomenson B. Cluster analysis of symptoms and health seeking behaviour differentiates subgroups of patients with severe irritable bowel syndrome. Gut. 2003 Nov;52(11):1616-22. doi: 10.1136/gut.52.11.1616.
- Background: PubMed 7635853Masand PS, Kaplan DS, Gupta S, Bhandary AN, Nasra GS, Kline MD, Margo KL. Major depression and irritable bowel syndrome: is there a relationship? J Clin Psychiatry. 1995 Aug;56(8):363-7.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paroxetine CR in people with Depressive Disorder, run by GlaxoSmithKline.
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 4 inclusion and 14 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: withdrawn, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
HDRS-17 (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01916200, which also lists 22 linked publications.
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 16 Jul 2014.