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Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01352559
Enrollment
1000
Registered
2011-05-12
Start date
2001-11-30
Completion date
2018-12-31
Last updated
2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Pharmacogenomics, Prediction of Antidepressant Response, Depressed Patients, biomarkers, phenotype, Antidepressant Response, Adverse Reaction to Drug

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.

Interventions

Antidepressants administration for 6 weeks under therapeutic dose

Antidepressants administration for 6 weeks under therapeutic dose

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 89 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Antidepressant Response at 6 weeks6 weeksantidepressant response is defined as the decrease rate of HAM-D score for 6week was = or \> 50% Measurement Unit = responders, nonresponders

Secondary

MeasureTime frameDescription
Biological value at 0 and 6 weeks6 weeksBiological 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)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026