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Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Information source: Samsung Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depression; Antidepressant Drug Adverse Reaction

Intervention: SSRI treated group (Drug); non-SSRI treated group (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Doh Kwan Kim, M.D.,Ph.D., Principal Investigator, Affiliation: Samsung Medical Center

Overall contact:
Doh Kwan Kim, M.D.,Ph.D, Phone: 82-2-3410-0946, Email: jungshil.back@sbri.co.kr

Summary

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

Clinical Details

Official title: Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: all pharmacogenetic and biological marker variables cause drug response

Secondary outcome: all clinical cause drug response

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.

Eligibility

Minimum age: 25 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 25 < age <85 2. major depressed patients satisfied with the diagnosis criteria depression of DSM-IV 3. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians Exclusion Criteria: 1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks 2. 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.

Locations and Contacts

Doh Kwan Kim, M.D.,Ph.D, Phone: 82-2-3410-0946, Email: jungshil.back@sbri.co.kr

Samsung Medical Center, Kangnam, Seoul 135-710, Korea, Republic of; Recruiting
DohKwan Kim
Doh Kwan Kim, ph.D, M.D., Principal Investigator
Additional Information

Starting date: April 2006
Last updated: June 4, 2015

Page last updated: August 23, 2015

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