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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01352572
First received: April 21, 2011
Last updated: June 4, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Depression
Drug: antidepressant response
Drug: antidepressant non-response

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Antidepressant Response at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

    Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50%

    Measurement Unit = responders, nonresponders



Secondary Outcome Measures:
  • Biological value at 0 and 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

    Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte.

    Measurement value : Optical Density(O.D), microgram/liter(ug/l)



Estimated Enrollment: 300
Study Start Date: January 2002
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: antidepressant response
antidepressant response are refered the patients having a 50 ≤ Decrease rate(%) of HAM-D score
Drug: antidepressant response
Antidepressants administration for 6 weeks under therapeutic dose responders
Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
  • milnacipran
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron
Active Comparator: antidepressant non-response
antidepressant non-response are refered the patients having a 50 > Decrease rate(%) of HAM-D score
Drug: antidepressant non-response
Antidepressants administration for 6 weeks under therapeutic dose nonresponders
Other Names:
  • fluoxetine, paroxetine, sertraline
  • milnacipran, venlafaxine, nortriptyline, mirtazapine

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352572

Contacts
Contact: Jung Shil Beck, B Sc 82-2-3410-0946 jungshil.back@sbri.co.kr
Contact: Shinn-Won Lim, phD 82-2-3410-3759 shinwon.lim@sbri.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of, 135-710
Contact: Samsung Medical Center IRB    82-2-3410-1847      
Contact: Shinn-Won Lim, phD    82-2-3410-3759    shinwon.lim@sbri.co.kr   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Doh Kwan Kim, MD PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Doh Kwan Kim, M.D., pHD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01352572     History of Changes
Other Study ID Numbers: 2002-09-08
Study First Received: April 21, 2011
Last Updated: June 4, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Antidepressant Response
Signal Transduction
Lymphocyte
Biomarkers
Depressed Patients
Antidepressant Drug Adverse Reaction

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Fluoxetine
Milnacipran
Mirtazapine
Nortriptyline
Paroxetine
Sertraline
Venlafaxine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic Uptake Inhibitors
Adrenergic alpha-Antagonists
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on September 03, 2015