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

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.