Controlled-release Paroxetine in Major Depressive Disorder (Double-blind, Placebo-controlled Study)
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
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.