Adverse Reaction to Drug, Depression
Conditions
Keywords
Pharmacogenomics, Prediction of Antidepressant Response, Depressed Patients
Brief summary
The purpose of this study is to determine whether pharmacogenomic study 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 1. to determine whether genomic effects on antidepressant response differed by class of drug, 2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and 3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.
Interventions
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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
| Measure | Time frame |
|---|---|
| Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Biological value at 0 and 6 weeks | 6weeks |
Countries
South Korea
Contacts
Primary ContactJungShil Back, B/Sc.
Backup ContactShinn-Won Lim, phD.
Outcome results
None listed