Desvenlafaxine Versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder.

ABSTRACT:

Objective

To evaluate the short-term efficacy and safety of desvenlafaxine versus placebo in the treatment of children and adolescents with major depressive disorder (MDD).

Methods

Outpatient children (7-11 years) and adolescents (12-17 years) who met DSM-IV-TR criteria for MDD and had screening and baseline Children's Depression Rating Scale-Revised (CDRS-R) total scores >40 were randomly assigned to 8 weeks of treatment with placebo, low exposure desvenlafaxine (20, 30, or 35 mg/day based on baseline weight), or higher exposure desvenlafaxine (25, 35, or 50 mg/day based on baseline weight). The primary efficacy endpoint was change from baseline in CDRS-R total score at week 8, analyzed using a mixed-effects model for repeated measures. Secondary efficacy assessments includ

SUBMITTER: Atkinson S 

PROVIDER: S-EPMC5771531 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature