Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2015 by Samsung Medical Center
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center Identifier:
First received: January 5, 2009
Last updated: December 30, 2015
Last verified: December 2015
The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Condition Intervention
Antidepressant Drug Adverse Reaction
Drug: SSRI treated group
Drug: non-SSRI treated group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all clinical cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: April 2006
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI treated group
SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline
Drug: SSRI treated group
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
Other Names:
  • Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
  • citalopram_Celexa
Active Comparator: non-SSRI treated group
non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
Drug: non-SSRI treated group
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
Other Names:
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron
  • bupropion_amfebutamone, Wellbutrin, Zyban
  • duloxetine_Cymbalta, Yentreve
  • trazodone_Desyrel, Beneficat, Deprax

Detailed Description:

The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects.

If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.


Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 25 < age <85
  2. major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
  3. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

  1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
  2. potential study participants for pregnancy, significant medical conditions, abnormal laboratory baseline values, unstable psychiatric features(eg.suicidal), history of alcohol of drug dependence, seizures, head trauma with loss of consciousness, 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 identifier: NCT00817011

Contact: Doh Kwan Kim, M.D.,Ph.D 82-2-3410-0946
Contact: Shinn-Won Lim, phD 82-2-3410-3759

Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of, 135-710
Contact: DohKwan Kim         
Principal Investigator: Doh Kwan Kim, ph.D, M.D.         
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Doh Kwan Kim, M.D.,Ph.D. Samsung Medical Center
  More Information

Responsible Party: Doh Kwan Kim, M.D., Ph.D, Samsung Medical Center Identifier: NCT00817011     History of Changes
Other Study ID Numbers: 2006-03-012 
Study First Received: January 5, 2009
Last Updated: December 30, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
antidepressant response
biological markers
clinical variables

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Tricyclic
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Adrenergic Agents
Adrenergic Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs processed this record on May 30, 2016