Clinical Pharmacogenomics of Antidepressant Response
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00269334|
Recruitment Status : Unknown
Verified December 2005 by National Health Research Institutes, Taiwan.
Recruitment status was: Not yet recruiting
First Posted : December 23, 2005
Last Update Posted : December 23, 2005
The study includes two components：(1) cross-sectional (Study I), and (2) longitudinal treatment trial (Study II). The cross-sectional component will include all subjects initially recruited for the parent project. Genotyping characteristics will be compared with clinical status (i.e., recovered vs symptomatic). The treatment trial component (one) will include a subset of the subjects (n = 400) who remain significantly depressed. They will be randomly assigned to 8-weeks of treatment with either citalopram or paroxetine. With such a design, we wish to test the following hypotheses：
Ⅰ. Depressed patients with the short variant of the serotonin transporter (5HTTLPR) will respond faster and better to antidepressants compared to their counterparts with the long variant. Concurrently, patients with the 5-HTT Stin2 12/12 allele will also show better response as compared to those with the 10/12 allele.
Ⅱ. Depressed patients who are homozygous for deficient or less active CYP2D6 or CYP2C19 enzyme(s) will be more likely to show treatment emergent side effects compared to subjects with the wildtype alleles. Specifically, in Study II, CYP2D6 polymorphism will predict PAR but not CIT side effects and CYP2C19 polymorphism will be associated with CIT but not PAR side effects.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Drug: Using Citalopram(drug) or Paroxetine(drug)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 4 Study of Clinical Pharmacogenomics of Antidepressant Response|
|Study Start Date :||December 2005|
|Estimated Study Completion Date :||November 2007|
- Using the following assessment instruments:
- Structured Clinical Interview for DSM-IV Disorders (SCID) at week baseline.
- Hamilton Depression Rating Scale (HAM-D) at week 1,2,4,6,8.
- Beck Depression Inventory (BDI) at week 1,2,4,6,8.
- Clinical Global Impression Scale (CGI) at week 1,2,4,6,8.
- Patient's Global Improvement Scale (PGI) at week 1,2,4,6,8.
- Treatment Emergent Symptoms Scale (TESS) at week 1,2,4,6,8.
- Arizona Sexual Experience Scale (ASEX) at week 1,2,4,6,8.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00269334
|Contact: Keh-Ming Lin, M.D., M.P.H.||+886-2-2653-4401 ext firstname.lastname@example.org|
|Jing-Ho Mental Hospital||Not yet recruiting|
|Kaohsiung, Taiwan, 824|
|Contact: Ching-Kuan Wu, M.D. +886-7-6156555 ext 108 email@example.com|
|Principal Investigator: Ching-Kuan Wu, M.D.|
|TSYR-HUEY(LOVING) Mental Hospital|
|Kaohsiung, Taiwan, 833|
|Taipei Municipal Wang-Feng Hospital||Not yet recruiting|
|Taipei, Taiwan, 116|
|Contact: Dlaire Teng, M.D. +886-2-2785-8523 ext 53958 firstname.lastname@example.org|
|Contact: Winston Shen, M.D. +886-2-2785-8523 ext 53958 shenwinw@AOL.com|
|Principal Investigator: Claire Teng, M.D.|
|Principal Investigator: Winston Shen, M.D.|
|Chang-Gung Memorial Hospital||Not yet recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Norase Hsiao, M.D. +886-3-3281200 ext 3854 email@example.com|
|Contact: Chia-Yi Liu, M.D. +886-3-3281200 ext 3854 firstname.lastname@example.org|
|Principal Investigator: Chia-Yi Liu, M.D.|
|Principal Investigator: Norase Hsiao, M.D.|
|Principal Investigator:||Winston Chen, M.D.||Taipei Municipal Wang-Feng Hospital|
|Principal Investigator:||Claire Deng, M.D.||Taipei Municipal Wang-Feng Hospital|
|Principal Investigator:||Jia-Yi Liu, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Norase Hsiao, M.D.||Chang Gung Memorial Hospital|
|Principal Investigator:||Jung-Kuang Wen, M.D.||JSYR-HUEY(LOVING) Mental Hospital|
|Principal Investigator:||Ching-Kuan Wu, M.D.||Jing-Ho Mental Hospital|