DepressionNCT00384020
Clinical Pharmacogenomics of Antidepressant Response
An observational study of Depression, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Paroxetine (Seroxat) and Escitalopram (Lexapro)
- How many people
- 402 participants
- Where
- 4 sitesTaiwan
- Study dates
- Jan 2006to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: depressive patients in Taiwan
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Song-De Branch, Taipei City Hospital
Taipei, Taipei, 11000
Municipal Wan Fang Hospital
Taipei, Taipei, 11600
Mackay Memorial Hospital
Taipei, Taipei, 25115
Chang Gung Memorial Hospital
Taoyuan, Taoyuan, 33305
About this study
Official title: Phase 4 Clinical Pharmacogenomics of Antidepressant Response
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Paroxetine (Seroxat), Escitalopram (Lexapro)
- Keywords
- Major Depression Disorder, Antidepressant, Pharmacogenomics, Cytochrome P450, Serotonin Transporter
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paroxetine (Seroxat)Drug
Escitalopram (Lexapro)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startJan 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital, Taipei Medical University WanFang Hospital, Taipei City Hospital, Mackay Memorial Hospital
- Investigators
- Keh-Ming Lin, MD, MPH, Study director, National Health Research Institutes, TaiwanChia-Hui Chen, MD, Principal investigator, National Health Research Institutes, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384020
- Sponsor's protocol ID
- MD-095-PP-01
- Other IDs
- NSC 95-2314-B-400-001
- Status last verified
- Jan 2010
- First submitted
- 3 Oct 2006
- Last updated
- 1 Feb 2010
- Results posted
- No
Publications
Tsai MH, Lin KM, Hsiao MC, Shen WW, Lu ML, Tang HS, Fang CK, Wu CS, Lu SC, Liu SC, Chen CY, Liu YL. Genetic polymorphisms of cytochrome P450 enzymes influence metabolism of the antidepressant escitalopram and treatment response. Pharmacogenomics. 2010 Apr;11(4):537-46. doi: 10.2217/pgs.09.168.
PubMed 20350136
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Clinical Pharmacogenomics of Antidepressant Response
- ClinicalTrials.gov ID
- NCT00384020
- Acronym / sponsor ID
- MD-095-PP-01
- Conditions
- Depression
- Keywords
- Major Depression Disorder, Antidepressant, Pharmacogenomics, Cytochrome P450, Serotonin Transporter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, Chang Gung Memorial Hospital, Taipei Medical University WanFang Hospital, Taipei City Hospital, Mackay Memorial Hospital
- Study start
- Jan 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- depressive patients in Taiwan
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paroxetine (Seroxat) | Drug | – |
| Escitalopram (Lexapro) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2010.
- Derived from this study: PubMed 20350136Tsai MH, Lin KM, Hsiao MC, Shen WW, Lu ML, Tang HS, Fang CK, Wu CS, Lu SC, Liu SC, Chen CY, Liu YL. Genetic polymorphisms of cytochrome P450 enzymes influence metabolism of the antidepressant escitalopram and treatment response. Pharmacogenomics. 2010 Apr;11(4):537-46. doi: 10.2217/pgs.09.168.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keh-Ming Lin, MD, MPH study director
National Health Research Institutes, Taiwan
Chia-Hui Chen, MD principal investigator
National Health Research Institutes, Taiwan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384020, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2010.