Strategic use of new generation antidepressants for depression: SUN(^_^) D protocol update and statistical analysis plan.

ABSTRACT:

Background

SUN(^_^)D, the Strategic Use of New generation antidepressants for Depression, is an assessor-blinded, parallel-group, multicenter pragmatic mega-trial to examine the optimum treatment strategy for the first- and second-line treatments for unipolar major depressive episodes. The trial has three steps and two randomizations. Step I randomization compares the minimum and the maximum dosing strategy for the first-line antidepressant. Step II randomization compares the continuation, augmentation or switching strategy for the second-line antidepressant treatment. Step III is a naturalistic continuation phase. The original protocol was published in 2011, and we hereby report its updated protocol including the statistical analysis plan.

Results

We implemented two importa

SUBMITTER: Yonemoto N 

PROVIDER: S-EPMC4606498 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature