Status:
WITHDRAWN
Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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...
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 scree...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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).
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01916200
Start Date
January 1 2014
End Date
September 1 2014
Last Update
July 16 2014
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.