Last updated on June 2010

A six week randomized, double-blind, multi-center, placebo-contolled, exploratory, adaptive design study to explore the antidepressant properties of the p38 MAP kinase inhibitor GW856553 compound compared to placebo in adult subjects with Major Depressive Disorder.


Brief description of study

A six week randomized, double-blind, multi-center, placebo-contolled, exploratory, adaptive design study to explore the antidepressant properties of the p38 MAP kinase inhibitor GW856553 compound compared to placebo in adult subjects with Major Depressive Disorder.

Detailed Study Description

The purpose of this study is to test the safety of GW8556553 (the study drug) and how well it works at different doses. We are doing this study in patients with depression (Major Depressive Disorder) to find out:

  • 1. What are the effects of the drug, good or bad?
  • 2. How much of the drug gets into the blood?
The study drug is not approved for doctors to prescribe to patients. It has been given to more than 300 people in 13 earlier research studies.

Patient Inclusion Criteria:

  • Male or female greater than or equal to 18 years of age and less than or equal to 60 years of age
  • Meets the diagnosis for Major Depressive Disorder as diagnosed with a comprehensive psychiatric evaluation
  • At least one previous major depressive episode with a diagnosis of Major Depressive Disorder and is currently experiencing a recurrence

Patient Exclusion Criteria:

  • Active infectious disease
  • History of malignancy within two years
  • History of HIV or other immunosuppressive disorder
  • Uncontrolled diabetes
  • Pregnant or nursing
  • History of substance abuse or dependence within the past six months
  • Electroconvulsive therapy, transcranial magnetic stimulation or vagus nerve stimulation within six months prior to study participation
  • History or active seizure disorder

Clinical Study Identifier: TX134933

Contact Investigators or Research Sites near you

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AMITA Health

Hoffman Estates, IL USA
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Recruitment Status: Open


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