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Protocol Registration Receipt
Clinical Pharmacogenomics of Antidepressant Response
This study is currently recruiting patients.
Verified by National Health Research Institutes, Taiwan 2006-10 Sponsored by: National Health Research Institutes, Taiwan
National Science Council, TaiwanChang Gung Memorial HospitalMunicipal Wang-Fang Hospital, TaiwanSong-De, Taipei City Hospital, TaiwanMackay Memorial Hospital, Taiwan Information provided by: National Health Research Institutes, Taiwan
ClinicalTrials.gov
Identifier:
The purpose of this study is to understand how genetic polymorphisms influence the efficacy andside effect profiles of Paroxetine and Escitalopram for major depression treatment.
Condition
Treatment or Intervention
Study Type: ObservationalStudy Design: Natural History, Cross-Sectional, Defined Population, Retrospective/ProspectiveStudy Official Title: Phase 4 Clinical Pharmacogenomics of Antidepressant Response Study Start: 2006-01; Study Completion: 2008-12Last Follow-Up: 2008-12; Data Entry Closure: 2008-12 Despite remarkable progress in recent decades in modern psychopharmacotherapy, patients vary substantially in their response to antidepressants, ranging from total remission tocomplete treatment failure. Adverse effects, often bothersome and occasionallylife-threatening, continue to represent significant challenges to patients and clinicians.
Mechanisms responsible for such variability remain poorly understood. In addition, althoughless appreciated, substantial cross-ethnic variations in psychotropic responses often exist.
Recent developments in the field of pharmacogenetics indicate that genetic factors mayaccount for a large part of these differences in response. Specific genetic polymorphismsaffecting the function of the serotonin (SERT) system has been postulated to predict the effectof antidepressants. Similarly, genetic mutations have been shown to exert a predominantinfluence on the expression of a number of drug-metabolizing enzymes, including most of thecytochrome P-450 enzymes that are responsible for the biotransformation of mostantidepressants. Polymorphisms of genes controlling these enzymes have been found to bestrongly associated with the propensity for various kinds of side effects. Capitalizing on thesenew developments, the proposed study will examine the predictive value of some of thesegenetic polymorphisms in 400 patients with DSM-IV major depression prospectively treatedwith Escitalopram (ECIT) or Paroxetine (PAR). It is postulated that mutations affecting thefunction of SERT will predict responses to ECIT, polymorphism of CYP2C19 will be associatedwith the side effect profiles and pharmacokinetics of ECIT.
Eligibility
Ages Eligible for Study: 18 Years - N/A, Genders Eligible for Study: Both • self-identified as of Taiwanese/Chinese ethnic background, and report that both of their parents and all four or three of their grandparents are members of the same ethnic group; • HAMD-21 > 17 plus MDE (i.e., current major depressive episode) based on SCID;• male or female, who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devises or abstinence; • age >= 18;• capable of giving informed consent; • diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, bipolar disorders; • current drug or alcohol abuse or dependence or history of drug or alcohol abuse or • unstable medical or neurological conditions that are likely to interfere with the treatment of • history of allergy to antidepressants;• history of seizure disorder;• pregnancy;• active suicidal ideation or other safety issues determined by the clinician to not be suitable Location and Contact Information
886-2653-4401 Ext. 26703 yclin@nhri.org.tw Taiwan, Taipei
Song-De Branch, Taipei City Hospital, Taipei, Taipei, 11000, Taiwan; Recruiting Hwa-Sheng Tang, MD 886-2726-3141 Ext. 1352 hstang@tpech.gov.twHwa-Sheng Tang, MD, Principal Investigator Municipal Wan Fang Hospital, Taipei, Taipei, 11600, Taiwan; Recruiting Winston Shen, MD 886-2-2930-7930 Ext. 2835 shenwinw@AOL.comWinston Shen, MD, Principal Investigator Mackay Memorial Hospital, Taipei, Taipei, 25115, Taiwan; Recruiting Shen-Ing Liu, PhD 886-2-2809-4661 Ext. 3056 liuyip@ms23.hinet.netShen-Ing Liu, PhD, Principal Investigator Taiwan, Taoyuan
Chang Gung Memorial Hospital, Taoyuan, Taoyuan, 33305, Taiwan; Recruiting Chia-Yih Liu, MD 886-3-328-1200 Ext. 2439 liucy752@cgmh.org.twChia-Yih Liu, MD, Principal Investigator National Health Research Institutes, Taiwan Chia-Hui Chen, MD, Principal Investigator National Health Research Institutes, Taiwan National Health Research Institutes, Taiwan More Information
Study ID Numbers MD-095-PP-01; NSC 95-2314-B-400-001Health Authority: Taiwan: Department of Health

Source: http://tprn.nhri.org.tw/m0106/ClinicalTrials.gov%20Protocol%20Registration%20Receipt.pdf