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About
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.
Enrollment
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Inclusion criteria
<at the start of placebo run-in phase> Only the patients who meet all of the following conditions at Week -1 (at the start of placebo run-in phase) will be enrolled in this study. The hospitalization status will be no object. and Gender: No object.
For the purposes of these criteria, QTc B (Bazett's correction) is defined as (QT interval [msec]) /(square root of RR interval [seconds])
<at the start of treatment phase> Only the patients who meet all of the following conditions at Week -1 (at the start of the placebo run-in phase) and Week 0 (at the start of treatment phase) can be shifted to the treatment phase.
Exclusion criteria
<at the start of placebo run-in phase> The patients who are meeting any of the following conditions at Week -1 (at the start of placebo run-in phase) must not be enrolled in this study.
Exclusion criteria < at the start of treatment phase> The patients who are meeting any of the following conditions at Week 0 (at the start of treatment phase) must not be allowed to the treatment phase.
Primary purpose
Allocation
Interventional model
Masking
416 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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