NCT00384020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 1, 2010

Status Verified

January 1, 2010

Enrollment Period

4 years

First QC Date

October 3, 2006

Last Update Submit

January 29, 2010

Conditions

Keywords

Major Depression DisorderAntidepressantPharmacogenomicsCytochrome P450Serotonin Transporter

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

depressive patients in Taiwan

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Song-De Branch, Taipei City Hospital

Taipei, Taipei, 11000, Taiwan

Location

Municipal Wan Fang Hospital

Taipei, Taipei, 11600, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taipei, 25115, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, Taoyuan, 33305, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression

Interventions

ParoxetineEscitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Keh-Ming Lin, MD, MPH

    National Health Research Institutes, Taiwan

    STUDY DIRECTOR
  • Chia-Hui Chen, MD

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 4, 2006

Study Start

January 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

February 1, 2010

Record last verified: 2010-01

Locations