Clinical Study to Test a New Drug to Treat Major Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID

NCT00976560

Run by

GlaxoSmithKline

People needed

128

Starts

2009-09-25

Expected to finish

2010-07-07

Last updated by the study team

2017-11-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

Where it is running

• GSK Investigational Site — Hoffman Estates, Illinois, United States
• GSK Investigational Site — Park Ridge, Illinois, United States
• GSK Investigational Site — New York, New York, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Pazardzhik, Bulgaria
• GSK Investigational Site — Plovdiv, Bulgaria
• GSK Investigational Site — Rousse, Bulgaria
• GSK Investigational Site — Sofia, Bulgaria
• GSK Investigational Site — Tartu, Estonia
• GSK Investigational Site — Hüttenberg, Hesse, Germany
• GSK Investigational Site — Achim, Lower Saxony, Germany
• GSK Investigational Site — Westerstede, Lower Saxony, Germany
• GSK Investigational Site — Schwerin, Mecklenburg-Vorpommern, Germany
• GSK Investigational Site — Bielefeld, North Rhine-Westphalia, Germany
• GSK Investigational Site — Dresden, Saxony, Germany
• GSK Investigational Site — Berlin, Germany
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Moscow, Russia
• GSK Investigational Site — Saint Petersburg, Russia
• GSK Investigational Site — Samara, Russia
• GSK Investigational Site — Smolensk, Russia

Full record on ClinicalTrials.gov

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