Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning
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ClinicalTrials.gov Identifier: NCT00935246 |
Recruitment Status : Unknown
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center.
Recruitment status was: Active, not recruiting
First Posted : July 8, 2009
Last Update Posted : December 31, 2015
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Sponsor:
Samsung Medical Center
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
Tracking Information | ||||
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First Submitted Date ICMJE | July 7, 2009 | |||
First Posted Date ICMJE | July 8, 2009 | |||
Last Update Posted Date | December 31, 2015 | |||
Study Start Date ICMJE | December 2008 | |||
Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks [ Time Frame: 8 weeks ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
biological value at 0 week and 8 weeks [ Time Frame: 8 weeks ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning | |||
Official Title ICMJE | Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning | |||
Brief Summary | To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning). | |||
Detailed Description | The purposes of this study are:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Escitalopram
Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose
Other Name: Escitalopram : Lexapro
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* 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 | Unknown status | |||
Estimated Enrollment ICMJE |
202 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date ICMJE | December 2016 | |||
Actual Primary Completion Date | October 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 89 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00935246 | |||
Other Study ID Numbers ICMJE | 2008-12-042 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Doh Kwan Kim, Samsung Medical Center | |||
Study Sponsor ICMJE | Samsung Medical Center | |||
Collaborators ICMJE | H. Lundbeck A/S | |||
Investigators ICMJE |
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PRS Account | Samsung Medical Center | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |