Clinical Pharmacogenomics of Antidepressant Response
Recruitment status was: Not yet recruiting
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.
Drug: Using Citalopram(drug) or Paroxetine(drug)
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 4 Study of Clinical Pharmacogenomics of Antidepressant Response|
- 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.
|Study Start Date:||December 2005|
|Estimated Study Completion Date:||November 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269334
|Jing-Ho Mental Hospital|
|Kaohsiung, Taiwan, 824|
|TSYR-HUEY(LOVING) Mental Hospital|
|Kaohsiung, Taiwan, 833|
|Taipei Municipal Wang-Feng Hospital|
|Taipei, Taiwan, 116|
|Chang-Gung Memorial Hospital|
|Taoyuan, Taiwan, 333|
|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|