Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Samsung Medical Center
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Antidepressant Response at 6 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
- •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
Arms & Interventions
antidepressant response
antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score
Intervention: antidepressant response (Drug)
antidepressant non-response
antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score
Intervention: antidepressant non-response (Drug)
Outcomes
Primary Outcomes
Antidepressant Response at 6 weeks
Time Frame: 6 weeks
Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or \>50% Measurement Unit = responders, nonresponders
Secondary Outcomes
- Biological value at 0 and 6 weeks(6 weeks)
Investigators
Doh Kwan Kim
M.D., pHD
Samsung Medical Center