Depression
Conditions
Keywords
Antidepressant Response, Signal Transduction, Lymphocyte, Biomarkers, Depressed Patients, Antidepressant Drug Adverse Reaction
Brief summary
The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\ 6 weeks after drug administration, or represent the clinical status of depressed patients.
Detailed description
The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.
Interventions
DRUGantidepressant response
Antidepressants administration for 6 weeks under therapeutic dose responders
DRUGantidepressant non-response
Antidepressants administration for 6 weeks under therapeutic dose nonresponders
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea. 2. were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents
Exclusion criteria
* pregnancy * significant medical conditions * abnormal laboratory baseline values * unstable psychiatric features (e.g, suicidal attempt) * history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antidepressant Response at 6 weeks | 6 weeks | Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or \>50% Measurement Unit = responders, nonresponders |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biological value at 0 and 6 weeks | 6 weeks | Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte. Measurement value : Optical Density(O.D), microgram/liter(ug/l) |
Countries
South Korea
Outcome results
None listed