Tracking Information
Start Date ICMJE | September 2009 |
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Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: September 11, 2009) | Clinical antidepressant effects of GW856553 measured as change from baseline in the Bech Score (6-items HAMD 17) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00976560 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: September 11, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Clinical Study to Test a New Drug to Treat Major Depression |
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Official Title ICMJE | 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 |
Brief Summary | 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 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. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Major Depressive Disorder (MDD) |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 180 | ||||
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Estimated Completion Date | August 2010 | ||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Bulgaria, Estonia, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00976560 | ||||
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Responsible Party | Study Director, GSK | ||||
Study ID Numbers ICMJE | 113009 | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | January 2010 |