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

This study is currently recruiting participants.
Verified June 2012 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 29, 2012
Last verified: June 2012
History of Changes
  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: Antidepressants

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:

U.S. FDA Resources

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 2012
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: responders
50 ≤ Decrease rate(%) of HAM-D score
 Drug: Antidepressants
Antidepressants administration for 6 weeks under therapeutic dose
Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
  • milnacipran
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron
Active Comparator: non-responders
50 > Decrease rate(%) of HAM-D score
 Drug: Antidepressants
Antidepressants administration for 6 weeks under therapeutic dose
Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
  • milnacipran
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron

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
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, M Sc 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, M Sc     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 29, 2012
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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Nortriptyline
Milnacipran
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Serotonin Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 19, 2013