Status:
UNKNOWN
Clinical Pharmacogenomics of Antidepressant Response
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Science and Technology Council, Taiwan
Taipei Medical University WanFang Hospital
Conditions:
Major Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 pa...
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 fail...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study;
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00269334
Start Date
December 1 2005
End Date
November 1 2007
Last Update
December 23 2005
Active Locations (4)
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1
Jing-Ho Mental Hospital
Kaohsiung City, Taiwan, 824
2
TSYR-HUEY(LOVING) Mental Hospital
Kaohsiung City, Taiwan, 833
3
Taipei Municipal Wang-Feng Hospital
Taipei, Taiwan, 116
4
Chang-Gung Memorial Hospital
Taoyuan District, Taiwan, 333