Pharmacogenomic Study to Predict Antidepressant Responsiveness in 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:
NCT00817375
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012

January 5, 2009
June 29, 2012
February 2003
December 2008   (final data collection date for primary outcome measure)
Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Antidepressant Response at 2,4,6,8,12,24 weeks [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00817375 on ClinicalTrials.gov Archive Site
Biological value at 0 and 6 weeks [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]
Biological value at 0,2,4,8,12 and 24 weeks [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients
Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.

The purpose of this study is

  1. to determine whether genomic effects on antidepressant response differed by class of drug,
  2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and
  3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.
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
  • Adverse Reaction to Drug
  • Drug: SSRI class antidepressant
    Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
    Other Names:
    • fluoxetine_Prozac
    • paroxetine_Paxil, Seroxat
    • sertraline_Zoloft
  • Drug: non-SSRI class antidepressant
    Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
    Other Names:
    • milnacipran
    • venlafaxine_Effexor
    • nortriptyline_Aventyl, Pamelor, Noritren
    • mirtazapine_Avanza, Zispin, Remeron
  • Experimental: SSRI treated group
    SSRI treated with fluoxetine, paroxetine, or sertraline
    Intervention: Drug: SSRI class antidepressant
  • Active Comparator: non-SSRI treated group
    non-SSRI treated with milnacipran, venlafaxine, nortriptyline, 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
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Eligible patients were enrolled in the clinical trials program of hte Samsung Medical Center Geropsychiatry and Affective Disorder Clinics(Seoul, Korea). They received a semistructured diagnostic interview, the Samsung Psychiatric Evaluation Schedule. The affective disorder section of the Samsung Psychiatric Evaluation Schedule uses the Korean version of the structured clinical interview for the diagnostic and statistical manual of mental disorders, Fourth edition.
  2. 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
19 Years to 89 Years
Yes
Contact: JungShil Back, B/Sc. 82-2-3410-0946 jungshil.back@samsung.com
Contact: Shinn-Won Lim, M.Sc. 82-2-3410-3759 shinwon.lim@samsung.com
Korea, Republic of
 
NCT00817375
2003-01-12
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