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

NCT01916200 | Withdrawn Phase 4

• 1 other identifier: 117049
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• HDRS-17

  8 weeks

Secondary Outcomes (5)

• HDRS-17 item 10

  8 weeks

• CGI-I

  8 weeks

• CGI-S

  8 weeks

• WHOQOL

  8 weeks

• IBSSS

  8 weeks

Study Arms (2)

Paroxetine CR group

EXPERIMENTAL

Paroxetine CR plus IBS regular treatment group

Drug: Paroxetine CR

Blank group

NO INTERVENTION

IBS regular treatment group

Interventions

Paroxetine CR DRUG

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.

Paroxetine CR group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (22)

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  BACKGROUND

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MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07