Efficacy and Safety of Paroxetine Controlled Release for Major Depressive Disorder in Irritable Bowel Syndrome Patients
Status:
Withdrawn
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
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.