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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

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

Intervention: Mirtazapine (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:
JungShil Back, B/Sc., Phone: 82-2-3410-0946, Email: junshil.back@sbri.co.kr

Summary

The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

Clinical Details

Official title: Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

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

Primary outcome: Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks

Secondary outcome: Biological value at 0 and 6 weeks

Detailed description: The purpose of this study is 1. to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and 2. to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Eligibility

Minimum age: 19 Years. Maximum age: 89 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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. 2. 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

JungShil Back, B/Sc., Phone: 82-2-3410-0946, Email: junshil.back@sbri.co.kr

Samsung Medical Center, Kangnam, Seoul 135-710, Korea, Republic of; Recruiting
Samsung Medical Center Kim, phD, MD, Phone: 82-2-3410-3582, Email: dohkwan.kim@samsung.com
Additional Information

Starting date: February 2003
Last updated: June 4, 2015

Page last updated: August 23, 2015

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