Conditions: Depressive Disorder
Keywords: paroxetine selective serotonin reuptake inhibitor CDRS-R children and adolescents
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
This study is designed to compare the efficacy of oral paroxetine 10 to 40 mg/day (initial dose:10 mg/day) versus placebo administered once daily (after evening meal) for 8 weeks in children and adolescents with major depressive disorder (MDD) based on the change from baseline to Week 8/end-of-study in the CDRS-R total score in a randomized, double-blind, placebo-controlled parallel-group study.

Detailed description:

Arms:
arm 1: paroxetine 10-40mg/day arm 2: matched placebo to paroxetine

Interventions: intervention 1: paroxetine 10mg tablet intervention 2: paroxetine 20mg tablet intervention 3: matched placebo to paroxetine 10mg intervention 4: matched placebo to paroxetine 20mg
Intervention descriptions: intervention 1: 1 or 2 tablet(s) once a day intervention 2: 1 tablet once a day intervention 3: 2 tablets once a day intervention 4: 1 tablet once a day

Protocol document: