Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

Not Applicable

• Conditions: Depression
• Interventions: Drug: responders; Drug: non-responders

• Registration Number: NCT01352559
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) 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 to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.

Study Timeline

• Study Start: 2001-11
• Primary Completion: 2007-03
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
responders	responders	50 ≤ Decrease rate(%) of HAM-D score
non-responders	non-responders	nonresponders is a patients having 50 \> Decrease rate(%) of HAM-D score

Primary Outcome Measures

Name	Time	Method
Antidepressant Response at 6 weeks	6 weeks	antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or \> 50%; Measurement Unit = responders, nonresponders

Secondary Outcome Measures

Name	Time	Method
Biological value at 0 and 6 weeks	6 weeks	Biological value is defined as; 1. Genetic information of bioamine transporter genes of patients. Measurement unit = if it is SNP,it is A, T, G, or C, and if VNTR, short or long allele; or; 2. Biological measure value of patients at 0 and 6week after antidepressant treatment(ex. peripheral markers such as serum BDNF, CREB...).; Measurement unit = numerical value and thier unit such as O.D.(Optical Density)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Kangnam, Seoul, Korea, Republic of