Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center Identifier:
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012

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 class antidepressant
Drug: non-SSRI class antidepressant

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 2015
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI treated group
SSRI treated with fluoxetine, paroxetine, citalopram or sertraline
Drug: SSRI class antidepressant
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 with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
Drug: non-SSRI class antidepressant
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
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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, M. Sc. 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

No publications provided

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: June 29, 2012
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
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses processed this record on March 26, 2015