Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)
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| First Received Date ICMJE | January 5, 2009 | ||||||||
| Last Updated Date | June 29, 2012 | ||||||||
| Start Date ICMJE | April 2006 | ||||||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00817011 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
all clinical cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness | ||||||||
| Official Title ICMJE | Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness | ||||||||
| Brief Summary | The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients. |
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| Detailed Description | The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects. If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | March 2015 | ||||||||
| Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 25 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00817011 | ||||||||
| Other Study ID Numbers ICMJE | 2006-03-012 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Doh Kwan Kim, Samsung Medical Center | ||||||||
| Study Sponsor ICMJE | Samsung Medical Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Samsung Medical Center | ||||||||
| Verification Date | June 2012 | ||||||||
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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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