Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients

This study has been withdrawn prior to enrollment.
(This study was Cancelled Before Active)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01916200
First received: August 1, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Drug: Paroxetine CR
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • HDRS-17 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HDRS-17 item 10 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-I [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • CGI-S [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • WHOQOL [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • IBSSS [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paroxetine CR group
Paroxetine CR plus IBS regular treatment group
Drug: Paroxetine CR
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.
No Intervention: Blank group
IBS regular treatment group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916200

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01916200     History of Changes
Other Study ID Numbers: 117049
Study First Received: August 1, 2013
Last Updated: July 14, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder
Depression
Irritable Bowel Syndrome
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014