Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)

Summary

This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy of controlled-release (CR) formulation of paroxetine orally administered to patients with major depressive disorder (MDD) at a dose level in the range of 25 - 50 mg/day (initial dose level, 12.5 or 25 mg/day) once daily after evening meal for 8 weeks based on the decrease in HAM-D (Hamilton Depression Rating Scale) total score, to evaluate the safety based on adverse events, laboratory data and vital signs, and to describe the efficacy and safety of immediate release (IR) formulation of paroxetine.

Timeline

Start

2009-04

Primary completion

2010-02

Completion

2010-02

Outcome

Met primary endpoint

registry Placebo vs Paroxetine CR; p <0.001; Mean Difference (Net) -2.4 (95% CI -3.8 to -1.1); ANCOVA NCT00866294 ↗

Publications

• Background Higuchi T, Hong JP, Jung HY, Watanabe Y, Kunitomi T, Kamijima K. Paroxetine controlled-release formulation in the treatment of major depressive disorder: a randomized, double-blind, placebo-controlled study in Japan and Korea. Psychiatry Clin Neurosci. 2011 Dec;65(7):655-63. doi: 10.1111/j.1440-1819.2011.02243.x. Epub 2011 Sep 6.

Drugs

Indications