Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Health Research Institutes, Taiwan National Science Council, Taiwan Taipei Municipal Wan Fang Hospital Chang Gung Memorial Hospital Jing-Ho Mental Hospital, Taiwan Tsyr-Huey Mental Hospital |
---|---|
Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00269334 |
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:
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.
Condition | Intervention | Phase |
---|---|---|
Major Depression |
Drug: Using Citalopram(drug) or Paroxetine(drug) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Factorial Assignment, Bio-equivalence Study |
Official Title: | Phase 4 Study of Clinical Pharmacogenomics of Antidepressant Response |
Estimated Enrollment: | 400 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | November 2007 |
Despite remarkable progress in recent decades in modern psychopharmacotherapy, patients vary substantially in their response to antidepressants, ranging from total remission to complete treatment failure. Adverse effects, often bothersome and occasionally life-threatening, continue to represent significant challenges to patients and clinicians. Mechanisms responsible for such variability remain poorly understood. In addition, although less appreciated, substantial cross-ethnic variations in psychotropic responses often exist. Recent developments in the field of pharmacogenetics indicate that genetic factors may account for a large part of these differences in response. Specific genetic polymorphisms affecting the function of the serotonin (SERT) system has been postulated to predict the effect of antidepressants. Similarly, genetic mutations have been shown to exert a predominant influence on the expression of a number of drug-metabolizing enzymes, including most of the cytochrome P-450 enzymes (e.g., CYP2C19 and CYP3A4) that are responsible for the biotransformation of most antidepressants. Polymorphisms of genes controlling these enzymes have been found to be strongly associated with the propensity for various kinds of side effects. Capitalizing on these new developments, the proposed study will examine the predictive value of some of these genetic polymorphisms in 400 patients with DSM-IV major depression prospectively treated with citalopram (CIT). It is postulated that mutations affecting the function of SERT will predict responses to CIT, polymorphism of CYP2C19 will be associated with the side effect profiles and pharmacokinetics of CIT. The proposed study represents an extension and replication of a 5-year NIH/NIMH collaborative project that had designed and initiated in 2001 by the PI, which is currently ongoing at three sites in the U.S. ( “Ethnic Variations in Antidepressant Response” 1 R01 MH62421; 1R01MH626761R01MH62531, 07/01 - 06/06). In the original study, the inclusion of the two comparison groups, African Americans and Caucasians, whose genetic mutation patterns diverge significantly from each other, will allow us to examine how these differences affect their antidepressant response patterns and whether the associations are “replicable” across ethnicity. Results will be pooled with those derived from other sites, and will represent a rare opportunity to compare findings across Taiwanese, African American and Caucasian subjects with comparable diagnosis and treated with an identical protocol.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Keh-Ming Lin, M.D., M.P.H. | +886-2-2653-4401 ext 26703 | linkeh@nhri.org.tw |
Taiwan | |
Taipei Municipal Wang-Feng Hospital | |
Taipei, Taiwan, 116 | |
Chang-Gung Memorial Hospital | |
Taoyuan, Taiwan, 333 | |
TSYR-HUEY(LOVING) Mental Hospital | |
Kaohsiung, Taiwan, 833 | |
Jing-Ho Mental Hospital | |
Kaohsiung, Taiwan, 824 |
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 |
Study ID Numbers: | EC0931204, NSC 94-2314-B-400 -001 - |
Study First Received: | December 22, 2005 |
Last Updated: | December 22, 2005 |
ClinicalTrials.gov Identifier: | NCT00269334 History of Changes |
Health Authority: | Taiwan: Department of Health |
antidepressant,major depression,CYP2D6,CYP2C19,SSRI |
Depression Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Citalopram Paroxetine Serotonin Uptake Inhibitors |
Behavioral Symptoms Cytochrome P450 (2D6) Mental Disorders Mood Disorders Dexetimide Antidepressive Agents |
Depression Mental Disorders Therapeutic Uses Psychotropic Drugs Mood Disorders Depressive Disorder, Major |
Depressive Disorder Central Nervous System Agents Pharmacologic Actions Antidepressive Agents Behavioral Symptoms |