Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Samsung Medical Center300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Depression

Interventions

antidepressant responseDRUG

Antidepressants administration for 6 weeks under therapeutic dose responders

antidepressant non-responseDRUG

Antidepressants administration for 6 weeks under therapeutic dose nonresponders

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Kangnam, Seoul, South Korea

Outcomes

Primary Outcomes

Antidepressant Response at 6 weeks

Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or \>50% Measurement Unit = responders, nonresponders

Time frame: 6 weeks

Secondary Outcomes

Biological value at 0 and 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)

Time frame: 6 weeks

Data from ClinicalTrials.gov

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