Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

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:
NCT00817011
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012

January 5, 2009
June 29, 2012
April 2006
March 2008   (final data collection date for primary outcome measure)
all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00817011 on ClinicalTrials.gov Archive Site
all clinical cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Depression
  • Antidepressant Drug Adverse Reaction
  • 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
  • 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
  • Experimental: SSRI treated group
    SSRI treated with fluoxetine, paroxetine, citalopram or sertraline
    Intervention: Drug: SSRI class antidepressant
  • Active Comparator: non-SSRI treated group
    non-SSRI treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
    Intervention: Drug: non-SSRI class antidepressant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
March 2015
March 2008   (final data collection date for primary outcome measure)

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.
Both
25 Years to 85 Years
Yes
Contact: Doh Kwan Kim, M.D.,Ph.D 82-2-3410-0946 jungshil.back@sbri.co.kr
Contact: Shinn-Won Lim, M. Sc. 82-2-3410-3759 shinwon.lim@sbri.co.kr
Korea, Republic of
 
NCT00817011
2006-03-012
Yes
Doh Kwan Kim, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Doh Kwan Kim, M.D.,Ph.D. Samsung Medical Center
Samsung Medical Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP