Conditions: Depression Major Depressive Disorder
Keywords: MDD Child Adolescent Pharmacokinetic Outpatient Pediatrics Depressive Disorder Major
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 59
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to test the safety and tolerability of single ascending doses of Desvenlafaxine Succinate Sustained-Release (DVS SR) in both child and adolescent outpatients with major depressive disorder. This study will also characterize the pharmacokinetic profile of DVS SR in children and adolescents with major depressive disorder.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Intervention descriptions: intervention 1: DVS SR Tablets of 10mg, 25mg, 50mg, and 100mg. Assigned DVS SR daily doses of 10mg, 25mg, 50mg, 100mg, or 200mg for up to 8 weeks.

Protocol document: