Conditions: Depressive Disorder
Keywords: Immediate-release formulation of paroxetine (paroxetine IR) HAM-D (17 items) Controlled-release formulation of paroxetine (paroxetine CR)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 416
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: controlled-release (CR) of paroxetine 12.5 to 50mg/day arm 2: Immediate-release (IR) of paroxetine 10 to 40mg/day as a reference arm arm 3: matched placebo to both paroxetine CR and paroxetine IR

Interventions: intervention 1: paroxetine IR 10mg tablet intervention 2: paroxetine IR 20mg tablet intervention 3: matched placebo to paroxetine IR 10mg or 20mg intervention 4: Paroxetine CR 12.5mg tablet intervention 5: Paroxetine CR 25mg tablet intervention 6: matched placebo to paroxetine CR 12.5mg or 25mg
Intervention descriptions: intervention 1: 1 or 2 tablets once a day intervention 2: 1 tablet once a day intervention 3: 1 or 2 tablets once a day intervention 4: 1 or 2 tablets once a day intervention 5: 1 or 2 tablets once a day intervention 6: 1 or 2 tablets once a day

Protocol document: