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大うつ病性障害における徐放性パロキセチン（二重盲検プラセボ対照試験）
基本情報
- NCT ID
- NCT00866294
- ステータス
- 完了
- 試験のフェーズ
- 第3相
- 試験タイプ
- 介入
- 目標被験者数
- 416
- 治験依頼者名
- GlaxoSmithKline
概要
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.
対象疾患
Depressive Disorder
介入
paroxetine IR 10mg tablet(DRUG)
paroxetine IR 20mg tablet(DRUG)
matched placebo to paroxetine IR 10mg or 20mg(DRUG)
Paroxetine CR 12.5mg tablet(DRUG)
Paroxetine CR 25mg tablet(DRUG)
matched placebo to paroxetine CR 12.5mg or 25mg(DRUG)
依頼者（Sponsor）
グラクソ・スミスクライン株式会社(INDUSTRY)