Skip to main content
Clinical Trials/NCT00817375
NCT00817375
Unknown
N/A

Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

Samsung Medical Center1 site in 1 country1,000 target enrollmentFebruary 2003

Overview

Phase
N/A
Intervention
SSRI treated group
Conditions
Depression
Sponsor
Samsung Medical Center
Enrollment
1000
Locations
1
Primary Endpoint
Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.

Detailed Description

The purpose of this study is 1. to determine whether genomic effects on antidepressant response differed by class of drug, 2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and 3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.

Registry
clinicaltrials.gov
Start Date
February 2003
End Date
December 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Doh Kwan Kim

M.D., pHD

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

  • Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
  • interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria

  • received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
  • potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, neurological illness, or concomitant Axis I psychiatric disorder.

Arms & Interventions

SSRI treated group

SSRI treated group is depressive patients treated with fluoxetine, paroxetine, or sertraline

Intervention: SSRI treated group

non-SSRI treated group

non-SSRI treated group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine

Intervention: non-SSRI treated group

Outcomes

Primary Outcomes

Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks

Time Frame: 6 weeks

Secondary Outcomes

  • Biological value at 0 and 6 weeks(6weeks)

Study Sites (1)

Loading locations...

Similar Trials