Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Samsung Medical Center1 site in 1 country1,000 target enrollmentApril 2006

ConditionsDepression Antidepressant Drug Adverse Reaction

InterventionsSSRI treated group non-SSRI treated group

DrugsSSRI treated group non-SSRI treated group

Overview

Phase: N/A
Intervention: SSRI treated group
Conditions: Depression
Sponsor: Samsung Medical Center
Enrollment: 1000
Locations: 1
Primary Endpoint: all pharmacogenetic and biological marker variables cause drug response
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Detailed Description

The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects. If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

March 2018

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Medical Center

Responsible Party

Principal Investigator

Doh Kwan Kim

M.D., Ph.D

Samsung Medical Center

Eligibility Criteria

Inclusion Criteria

•25 \< age \<85
•major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
•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.