An Efficacy and Safety Study of Sirukumab in Participants With Major Depressive Disorder
Status:
Completed
Trial end date:
2018-05-22
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy of sirukumab as adjunctive treatment to
antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50
milligram (mg) subcutaneous (SC) injection at Day 1, Day 28 and Day 56 during the 12- week
double-blind treatment period) is compared to adjunctive placebo based on the change from
baseline to 12-week endpoint in depressive symptoms as measured by the total score on the
Hamilton Depression Rating Scale (HDRS), in participants diagnosed with Major Depressive
Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant
therapy and have a screening high sensitivity C-Reactive Protein (hsCRP) >=0.300 milligram
per deciliters (mg/dL) (International System of Units (SI) 3.00 mg/L). A cohort of subjects
with hsCRP <0.300 milligram per deciliter will also be enrolled to allow a better
understanding of the relationship between CRP and clinical changes.