NCT00269334

Brief Summary

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： Ⅰ. 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. Ⅱ. Depressed patients who are homozygous for deficient or less active CYP2D6 or CYP2C19 enzyme(s) will be more likely to show treatment emergent side effects compared to subjects with the wildtype alleles. Specifically, in Study II, CYP2D6 polymorphism will predict PAR but not CIT side effects and CYP2C19 polymorphism will be associated with CIT but not PAR side effects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

4 active sites

Status
unknown

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

December 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

December 23, 2005

Status Verified

December 1, 2005

First QC Date

December 22, 2005

Last Update Submit

December 22, 2005

Conditions

Major Depression

Keywords

antidepressant,major depression,CYP2D6,CYP2C19,SSRI

Outcome Measures

Primary Outcomes (8)

  • Using the following assessment instruments:

  • Structured Clinical Interview for DSM-IV Disorders (SCID) at week baseline.

  • Hamilton Depression Rating Scale (HAM-D) at week 1,2,4,6,8.

  • Beck Depression Inventory (BDI) at week 1,2,4,6,8.

  • Clinical Global Impression Scale (CGI) at week 1,2,4,6,8.

  • Patient's Global Improvement Scale (PGI) at week 1,2,4,6,8.

  • Treatment Emergent Symptoms Scale (TESS) at week 1,2,4,6,8.

  • Arizona Sexual Experience Scale (ASEX) at week 1,2,4,6,8.

Interventions

Using Citalopram(drug) or Paroxetine(drug)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • self-identified as of Taiwanese ethnic background, and report that both of their parents and all four of their grandparents are members of the same ethnic group;
  • non-responders: have a 21-item HAM-D score of \> 17; partial responders: have a 21-item HAM-D score between 8 and 15; responders: have a 21-item HAM-D score of \< 7. Only the non-responder group will be included in Study II.
  • 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 or 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)

Jing-Ho Mental Hospital

Kaohsiung City, 824, Taiwan

Location

TSYR-HUEY(LOVING) Mental Hospital

Kaohsiung City, 833, Taiwan

Location

Taipei Municipal Wang-Feng Hospital

Taipei, 116, Taiwan

Location

Chang-Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keh-Ming Lin, M.D., M.P.H.

CONTACT

+886-2-2653-4401linkeh@nhri.org.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

December 1, 2005

Study Completion

November 1, 2007

Last Updated

December 23, 2005

Record last verified: 2005-12

Locations

TW(4)