Depression
Conditions
Keywords
Pharmacogenomics, Prediction of Mirtazapine response, Depressed patients, Mirtazapine response, Adverse event
Brief 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.
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.
Interventions
DRUGMirtazapine
Mirtazapine administration for 6 weeks under therapeutic dose
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 89 Years
Healthy volunteers
No
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 |
|---|---|
| Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Biological value at 0 and 6 weeks | 6 weeks |
Countries
South Korea
Contacts
Primary ContactJungShil Back, B/Sc.
Backup ContactShinn-won Lim, M.Sc.
Outcome results
None listed