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

Samsung Medical Center

Status: Unknown

Conditions: Depression

Treatments: Drug: antidepressant non-response; Drug: antidepressant response

Study type: Interventional

Funder types: Other

Identifiers

NCT01352572

2002-09-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

antidepressant response

Experimental group

Description:

antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score

Treatment:

Drug: antidepressant response

antidepressant non-response

Active Comparator group

Description:

antidepressant non-response are refered the patients having a 50 \> Decrease rate(%) of HAM-D score

Treatment:

Drug: antidepressant non-response