Stopped: Negative data from a GSK PoC study in RA combined with evidence of greater sensitivity of toll-like receptor pathways to p38 inhibition.
GW856553 is a novel compound, currently in development for the treatment of Major Depressive Disorder (MDD), and other indications. GW856553 inhibits a protein which is responsible for the production of some pro-inflammatory molecules, called cytokines. Increased blood levels of these molecules were seen in populations of MDD patients and this was more apparent in subjects with severe symptoms, psychomotor retardation and loss of energy. Aim of the present study is to assess whether GW856553, by inactivating this protein, is able to suppress the production of the cytokines, and ultimately relieving depression symptoms. In this study GW856553 or placebo is given to MDD patients 7.5md twice daily for 6 weeks.
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Change from Randomization at Week 6 in Bech subscale (6-item of 17-item Hamilton depression rating [HAMD-17] scale) score
Timeframe: Day 1 (Randomization, Week 0) and Week 6
Change from Randomization (Week 0) at Week 6 in Inventory for Depressive Symptomatology-Clinician rated (IDS-C) scale total score
Timeframe: Day 1 (Randomization, Week 0) and Week 6
Change from randomization (Week 0) at Week 6 in Quick Inventory of Depressive symptomatology 16 item self report (QIDS-SR16) scale total score
Timeframe: Day 1 (Randomization, Week 0) and Week 6
Change from Randomization (Week 0) at Week 6 in the morning serum levels of the pro-inflammatory biomarkers
Timeframe: Day 1 (Randomization, Week 0) and Week 6