Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 337
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: duloxetine intervention 2: Placebo intervention 3: fluoxetine
Intervention descriptions: intervention 1: 30-120 mg, PO, QD, for up to 38 weeks intervention 2: Capsules identical in appearance, color, taste and smell to study drug, orally (PO), once daily (QD). Dose: placebo, 6 capsules, QD for 10 weeks intervention 3: 10-40 milligram (mg), PO, QD, for up to 38 weeks

Protocol document: