A study to investigate the efficacy of sirukumab in addition to the current antidepressant treatment in adults with depression Badanie w celu oceny skuteczności sirukumabu jako leku wspomagając...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-005206-37

A study to investigate the efficacy of sirukumab in addition to the current antidepressant treatment in adults with depression Badanie w celu oceny skuteczności sirukumabu jako leku wspomagającego stosowanego w skojarzeniu z terapią przeciwdepresyjną u dorosłych pacjentów z dużą depresją

Femme et Homme

  • | Pays :
  • -
  • | Organes :
  • -
  • | Spécialités :
  • -

Extrait

To evaluate the efficacy of sirukumab as adjunctive treatment to antidepressant therapy (monoaminergic antidepressant) where sirukumab (administered as a 50mg 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 (HDRS17), in subjects diagnosed with Major Depressive Disorder (MDD) who have had a suboptimal response to the current standard oral antidepressant therapy and have a screening and baseline high sensitivity C-Reactive Protein (hsCRP) ≥0.300 mg/dL (International System of Units (SI)


Critère d'inclusion

  • depression,Depresja

Liens