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Clinical Pharmacogenomics of Antidepressant Response

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ClinicalTrials.gov Identifier: NCT00384020
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : February 1, 2010
Sponsor:
Collaborators:
National Science Council, Taiwan
Chang Gung Memorial Hospital
Taipei Medical University WanFang Hospital
Taipei City Hospital
Mackay Memorial Hospital
Information provided by:
National Health Research Institutes, Taiwan

Brief Summary:
The purpose of this study is to understand how genetic polymorphisms influence the efficacy and side effect profiles of Paroxetine and Escitalopram for major depression treatment.

Condition or disease Intervention/treatment
Depression Drug: Paroxetine (Seroxat) Drug: Escitalopram (Lexapro)

Detailed Description:
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 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 Escitalopram (ECIT) or Paroxetine (PAR). It is postulated that mutations affecting the function of SERT will predict responses to ECIT, polymorphism of CYP2C19 will be associated with the side effect profiles and pharmacokinetics of ECIT.

Study Type : Observational
Actual Enrollment : 402 participants
Observational Model: Case-Only
Official Title: Phase 4 Clinical Pharmacogenomics of Antidepressant Response
Study Start Date : January 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
depressive patients in Taiwan
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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 dependence within the past 6 months;
  • unstable medical or neurological conditions that are likely to interfere with the treatment of depression;
  • 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 for inclusion in the study;

Information from the National Library of Medicine

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): NCT00384020


Locations
Taiwan
Song-De Branch, Taipei City Hospital
Taipei, Taiwan, 11000
Municipal Wan Fang Hospital
Taipei, Taiwan, 11600
Mackay Memorial Hospital
Taipei, Taiwan, 25115
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Science Council, Taiwan
Chang Gung Memorial Hospital
Taipei Medical University WanFang Hospital
Taipei City Hospital
Mackay Memorial Hospital
Investigators
Study Director: Keh-Ming Lin, MD, MPH National Health Research Institutes, Taiwan
Principal Investigator: Chia-Hui Chen, MD National Health Research Institutes, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00384020     History of Changes
Other Study ID Numbers: MD-095-PP-01
NSC 95-2314-B-400-001
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: February 1, 2010
Last Verified: January 2010

Keywords provided by National Health Research Institutes, Taiwan:
Major Depression Disorder
Antidepressant
Pharmacogenomics
Cytochrome P450
Serotonin Transporter

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Antidepressive Agents
Citalopram
Paroxetine
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors