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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 4, 2002 | ||||
| Last Updated Date | July 30, 2008 | ||||
| Start Date ICMJE | May 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months [ Time Frame: after 10 weeks of treatment and over 6-10 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Total HAMD-17 score </= 10 after 10 weeks of treatment, time to relapse of depression over 6-10 months | ||||
| Change History | Complete list of historical versions of study NCT00048594 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6. [ Time Frame: Week 10 at Month 6 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
CGI-S score change from Week 10 at Month 6; HAMD-17 total score change from Week 10 at Month 6; an HAMA total score change from week 10 at Month 6. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Long Term Treatment of Patients With Major Depressive Disorder With MK0869 | ||||
| Official Title ICMJE | A Double-Blind, Placebo-Controlled, Multicenter Study of the Long-Term Efficacy of MK0869 in the Maintenance of Antidepressant Effect in Patients With Major Depressive Disorder | ||||
| Brief Summary | A clinical study to determine the efficacy and safety of an investigational medication (MK0869) in the treatment of depression. |
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| Detailed Description | The duration of treatment is 20 months. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Major Depressive Disorder | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 800 | ||||
| Completion Date | March 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Patients with Major Depressive Disorder |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | |||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00048594 | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
| Study ID Numbers ICMJE | 2006_405, Formally-35MRB2, MK0869-065 | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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