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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2018

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

  • Drug: antidepressant response
    • Antidepressants administration for 6 weeks under therapeutic dose responders
  • Drug: antidepressant non-response
    • Antidepressants administration for 6 weeks under therapeutic dose nonresponders

Arms, Groups and Cohorts

  • Experimental: antidepressant response
    • antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score
  • Active Comparator: antidepressant non-response
    • antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Biological value at 0 and 6 weeks
    • Time Frame: 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)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Doh Kwan Kim, M.D., pHD – Samsung Medical Center
  • Overall Official(s)
    • Doh Kwan Kim, MD PhD, Principal Investigator, Samsung Medical Center

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