Clinical Pharmacogenomics of Antidepressant Response

Summary

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.

Conditions

• Major Depression

Interventions

DRUG

Using Citalopram(drug) or Paroxetine(drug)

Sponsors & Collaborators

• National Science and Technology Council, Taiwan

  collaborator OTHER_GOV

• Taipei Medical University WanFang Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Jing-Ho Mental Hospital, Taiwan

  collaborator UNKNOWN

• Tsyr-Huey Mental Hospital

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Winston Chen, M.D. · Taipei Municipal Wang-Feng Hospital

• Claire Deng, M.D. · Taipei Municipal Wang-Feng Hospital

• Jia-Yi Liu, M.D. · Chang Gung Memorial Hospital

• Norase Hsiao, M.D. · Chang Gung Memorial Hospital

• Jung-Kuang Wen, M.D. · JSYR-HUEY(LOVING) Mental Hospital

• Ching-Kuan Wu, M.D. · Jing-Ho Mental Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Completion

2007-11-30

Countries

• Taiwan

Study Locations