Depressive Disorder Clinical Trial
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
Verified date | July 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
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 Oct;98(10):2209-18. — View Citation
Cho 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. — View Citation
Creed 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. — View Citation
Creed F, Ratcliffe J, Fernandez L, Tomenson B, Palmer S, Rigby C, Guthrie E, Read N, Thompson D. Health-related quality of life and health care costs in severe, refractory irritable bowel syndrome. Ann Intern Med. 2001 May 1;134(9 Pt 2):860-8. — View Citation
Cremonini 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. Review. — View Citation
Drossman DA, Camilleri M, Mayer EA, Whitehead WE. AGA technical review on irritable bowel syndrome. Gastroenterology. 2002 Dec;123(6):2108-31. Review. — View Citation
Drossman 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. — View Citation
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 Apr;11(2):395-402. — View Citation
Friedrich M, Grady SE, Wall GC. Effects of antidepressants in patients with irritable bowel syndrome and comorbid depression. Clin Ther. 2010 Jul;32(7):1221-33. doi: 10.1016/j.clinthera.2010.07.002. Review. — View Citation
Gros 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. — View Citation
Guthrie 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. — View Citation
Hillilä MT, Siivola MT, Färkkilä MA. Comorbidity and use of health-care services among irritable bowel syndrome sufferers. Scand J Gastroenterol. 2007 Jul;42(7):799-806. — View Citation
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. Review. Erratum in: Gastroenterology. 2006 Aug;131(2):688. — View Citation
Masand 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. — View Citation
Mertz HR. Irritable bowel syndrome. N Engl J Med. 2003 Nov 27;349(22):2136-46. Review. — View Citation
Mitchell CM, Drossman DA. Survey of the AGA membership relating to patients with functional gastrointestinal disorders. Gastroenterology. 1987 May;92(5 Pt 1):1282-4. — View Citation
Park 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. — View Citation
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 Dec;29(4):339-43. — View Citation
Sandler RS. Epidemiology of irritable bowel syndrome in the United States. Gastroenterology. 1990 Aug;99(2):409-15. — View Citation
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. 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;quiz 34-57. Review. — View Citation
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.
Vandvik PO, Lydersen S, Farup PG. Prevalence, comorbidity and impact of irritable bowel syndrome in Norway. Scand J Gastroenterol. 2006 Jun;41(6):650-6. — View Citation
* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HDRS-17 | 8 weeks | No | |
Secondary | HDRS-17 item 10 | 8 weeks | No | |
Secondary | CGI-I | 8 weeks | No | |
Secondary | CGI-S | 8 weeks | No | |
Secondary | WHOQOL | 8 weeks | No | |
Secondary | IBSSS | 8 weeks | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01316926 -
Paxil CR Bioequivalence Study Brazil
|
Phase 1 | |
Recruiting |
NCT06187454 -
Transcranial Direct Current Stimulation for Depression
|
N/A | |
Completed |
NCT04469322 -
Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression
|
N/A | |
Recruiting |
NCT05768126 -
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
|
Phase 4 | |
Completed |
NCT03219879 -
Telephone-administered Relapse Prevention for Depression
|
N/A | |
Recruiting |
NCT06038721 -
Unified Protocol: Community Connections
|
N/A | |
Completed |
NCT03043560 -
Study to Treat Major Depressive Disorder With a New Medication
|
Phase 2 | |
Completed |
NCT04091139 -
Research of Unified Protocol for the Treatment of Common Mental Disorders in Adolescents in Hong Kong
|
Phase 2/Phase 3 | |
Completed |
NCT00069459 -
Seasonal Affective Depression (SAD) Study
|
Phase 1 | |
Recruiting |
NCT05503966 -
Combining Antidepressants and Attention Bias Modification in Depression
|
N/A | |
Recruiting |
NCT03001245 -
Interpersonal Counseling (IPC) for Treatment of Depression in Adolescents
|
N/A | |
Completed |
NCT02939560 -
TMS for Adults With Autism and Depression
|
N/A | |
Completed |
NCT02542891 -
European Comparative Effectiveness Research on Internet-based Depression Treatment
|
N/A | |
Completed |
NCT02452892 -
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
|
N/A | |
Withdrawn |
NCT02238730 -
Ultrabrief Right Unilateral and Brief Pulse Bitemporal Electroconvulsive Therapy
|
N/A | |
Completed |
NCT02306551 -
Well Being And Resilience: Mechanisms of Transmission of Health and Risk
|
||
Completed |
NCT02224508 -
Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks
|
N/A | |
Completed |
NCT01407575 -
Buprenorphine for Treatment Resistant Depression
|
Phase 3 | |
Completed |
NCT01597661 -
Bupropion & Cardio Birth Defect (Slone)
|
N/A | |
Completed |
NCT01093053 -
Mind-Body Skills Groups for the Treatment of War Zone Stress in Military and Veteran Populations
|
N/A |