Tracking Information
Start Date ICMJE | April 2009 |
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Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 7, 2009) |
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Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00896363 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 7, 2009) | To investigate preliminary pharmacokinetic/pharmacodynamic relationships for GSK163090 in subjects with MDD. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Safety and Efficacy Study in Patients With Major Depressive Disorder |
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Official Title ICMJE | A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects With Major Depressive Disorder. |
Brief Summary | The purpose of this study is to test if GSK163090 can reduce the symptoms of depression. The safety and how well the body can handle the drug will also be investigated. The study will be conducted in Russia in hospitalised patients with severe depression. GSK163090 will be compared with placebo, which looks like the study drug but does not contain any active substance. Subjects will be given either the study drug or the matching placebo. |
Detailed Description | This is a randomised, multi-centre, double-blind, placebo-controlled, repeat dose, parallel group study in male and female patients with severe depression requiring hospitalization. Efficacy, safety and tolerability will be assessed in three treatment arms. The study will consist of a screening period, a treatment phase (up to 6 weeks) and a post-treatment follow-up visit. The study duration from screening to follow up will be approximately 9 weeks. Subjects who pass screening will be randomized on Day 1 to one of three treatment arms (low dose arm, high dose arm or placebo). Each treatment arm will contain approximately 50 subjects. The subject's depressive symptoms will be assessed using the HAMD17- CR. |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 150 | ||||
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Estimated Completion Date | June 2010 | ||||
Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 64 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00896363 | ||||
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Responsible Party | Study Director, GSK | ||||
Study ID Numbers ICMJE | 109035 | ||||
Study Sponsor ICMJE | GlaxoSmithKline | ||||
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Investigators ICMJE |
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Information Provided By | GlaxoSmithKline |