Last updated: 11/03/2018 20:00:21
Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome patients
GSK study ID
117049
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
HDRS-17
Timeframe: 8 weeks
Secondary outcomes:
HDRS-17 item 10
Timeframe: 8 weeks
CGI-I
Timeframe: 8 weeks
CGI-S
Timeframe: 8 weeks
WHOQOL
Timeframe: 8 weeks
IBSSS
Timeframe: 8 weeks
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Mertz HR. Irritable bowel syndrome. N Engl J Med, 2003; 349: 2136–46.
Creed F, Fernandes L, Guthrie E, et al. The cost-effectiveness of psychotherapy and paroxetine for severe irritable bowel syndrome. Gastroenterology 2003; 124: 303-317.
Francis 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; 11(2): 395-402.
Cho HS, Park JM, Lim CH, et al. Anxiety, depression and quality of life in patients with irritable bowel syndrome. Gut Liver. 2011; 5(1): 29-36.
Drossman DA, Li Z, Andruzzi E, et al. U.S. householder survey of functional gastrointestinal disorders: prevalence, sociodemog-raphy, and health impact. Dig Dis Sci, 1993; 38:1569–1580.
Longstreth GF, Thompson WG, Chey WD, et al. Functional bowel disorders. Gastroenterology, 2006; 130: 1480–91.
Russo MW, Gaynes BN, Drossman DA. A national survey of practice patterns of gastroenterologists with comparison to the past two decades. J Clin Gastroenterol, 1999; 29:339–343.
Gros DF, Antony MM, McCabe RE, et al. Frequency and severity of the symptoms of irritable bowel syndrome across the anxiety disorders and depression. J Anxiety Disord. 2009; 23(2): 290-6.
Sandler RS: Epidemiology of irritable bowel syndrome in the United States. Gastroenterology, 1990; 99:409–415.
Boyce 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; 98: 2209-2218.
Guthrie E, Creed F, Fernandes L et al. Cluster analysis of symptoms and health seeking behavior differentiates subgroups of patients with severe irritable bowel syndrome. Gut 2003; 52: 1616–22.
Masand PS, Kaplan DS, Gupta S, et al. Major depression and irritable bowel syndrome: is there a relationship? J Clin Psychiatry, 1995; 56: 363–7.
Vandvik PO, Lydersen S, Farup PG. Prevalence, comorbidity and impact of irritable bowel syndrome in Norway. Scand J Gastroenterol 2006; 41: 650-656.
Park JM, Choi MG, Cho YK, et al. Functional Gastrointestinal Disorders Diagnosed by Rome III Questionnaire in Korea. J Neurogastroenterol Motil. 2011; 17(3):279-86.
Cremonini F, Talley NJ. Irritable bowel syndrome: Epidemiology, natural history, health care seeking and emerging risk factors. Gastroenterol Clin North Am, 2005; 34: 189–204.
Hillilä MT, Siivola MT, Färkkilä MA. Comorbidity and use of health-care services among irritable bowel syndrome sufferers. Scand J Gastroenterol 2007; 42: 799-806.
Friedrich M, Grady SE, Wall GC. Effects of antidepressants in patients with irritable bowel syndromeand comorbid depression. Clin Ther. 2010; 32(7): 1221-33.
Creed F, Ratcliffe J, Fernandez L, et al. Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome. Ann Intern Med. 2001; 134:860–868.
Thompson W, Longstreth G, Drossman Deds. Functional bowel disorders and functional abdominal pain. In: Drossman DA, Corazziari E, Talley NJ, Thompson WG, Whitehead WE, eds. Rome II. The Functional Gastrointestinal Disorders, 2nd edn. McLean, VA: Degnon Associates, 2000: 351–432.
Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998; 59 (Suppl 20): 22–33.
Drossman DA, Camilleri M, Mayer EA, et al. AGA technical review on irritable bowel syndrome. Gastroenterology, 2002; 123: 2108–2131.
Mitchell CM, Drossman DA. Survey of the AGA membership relating to patients with functional gastrointestinal disorders. Gastroenterology, 1987; 92(5, Pt 1):1282–1284.
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
January 2014 to December 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
No
- 1.Meet the diagnostic for IBS according to ROME III;
- 2.Meet the diagnostic for MDD according to MINI;
- 1.Patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine CR [Seroxat CR®];
- 2.History of alcohol / drug dependence and schizophrenia; history of serious mental illness;
Inclusion and exclusion criteria
Inclusion criteria:
- 1.Meet the diagnostic for IBS according to ROME III; 2.Meet the diagnostic for MDD according to MINI; 3.Age≥18 and ≤ 65; 4.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.
Exclusion criteria:
- 1.Patients were also excluded if they had any medical condition that would contraindicate the use of paroxetine CR [Seroxat CR®]; 2.History of alcohol / drug dependence and schizophrenia; history of serious mental illness; 3.Major neurological deficits that interfere with the patient’s ability to understand the study procedures and provide a written informed consent; 4.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; 5.Suicide ideation; 6.Use monoamine oxidase inhibitors (MAOIs), benzodiazepines or other antidepressants within at least 14 days before study begin; 7.Other medical and psychological conditions prevent patients from participating in the study or signing informed consent; 8.Pregnant or lactating females, or anyone who plan to become pregnant during the study period; 9.Those who are known to currently participate a clinical trial; 10.Those patients with significant organ disease. GI disorders that are infectious; 11.Ischemic, radiation-induced, or medication-induced; inflammatory bowel disease (Cohn’s disease and ulcerative colitis); 12.Recent gastrointestinal surgery (within 6 months). 13.Has received electroconvulsive therapy (ECT) or psychotherapy in the 3 months prior to screening. 14.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).
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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