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

Not Applicable

• Conditions: Depression
• Interventions: Drug: antidepressant non-response; Drug: antidepressant response

• Registration Number: NCT01352572
• Lead Sponsor: Samsung Medical Center

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 Timeline

• Study Start: 2002-01
• Study First Submitted: 2011-04-21
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Kangnam, Seoul, Korea, Republic of