Depressive Disorder, Major Clinical Trial
Official title:
A Six Week Randomized, Double-blind, Multi-center, Placebo-controlled, Exploratory, Adaptive Design Study to Explore the Antidepressant Properties of the p38 MAP Kinase Inhibitor GW856553 Compared to Placebo in Adult Subjects With Major Depressive Disorder
In this randomized, double-blind, multi-centre, placebo controlled, exploratory, adaptive
design study, the antidepressant and plasma cytokine lowering effects of the GW856553 will be
investigated in adult subjects diagnosed with MDD. Subjects will receive oral doses of
GW856553 or placebo for six weeks. Safety, tolerability, pharmacokinetics and
pharmacodynamics, defined as biomarkers in blood and clinical symptoms, will be assessed.
The primary endpoint is the change from baseline associated with GW856553 versus placebo at
Week 6 in the Bech (6-item HAMD-17) score. Interim analyses of the primary endpoint will be
performed throughout the study to potentially adapt the study design by changing the
randomization ratio and/ or reducing the total number of subjects to be randomized into the
study. Exploratory analyses will be performed by associating changes in cytokine levels and
selected clinical symptoms; PK/PD modelling will also be used to identify the most sensitive
clinical and biological markers.
n/a
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