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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01916200
Recruitment Status : Withdrawn (This study was Cancelled Before Active)
First Posted : August 5, 2013
Last Update Posted : July 16, 2014
Information provided by (Responsible Party):

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 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 or disease Intervention/treatment Phase
Depressive Disorder Drug: Paroxetine CR Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2014
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. HDRS-17 [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. HDRS-17 item 10 [ Time Frame: 8 weeks ]
  2. CGI-I [ Time Frame: 8 weeks ]
  3. CGI-S [ Time Frame: 8 weeks ]
  4. WHOQOL [ Time Frame: 8 weeks ]
  5. IBSSS [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01916200

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

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.

Responsible Party: GlaxoSmithKline Identifier: NCT01916200     History of Changes
Other Study ID Numbers: 117049
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Irritable Bowel Syndrome
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors