Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center Identifier:
First received: April 21, 2011
Last updated: June 4, 2015
Last verified: June 2015
The purpose of this study is to determine whether pharmacogenomic study of bioamine transporters and peripheral lymphatic biomarkers(phenotype) predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.

Condition Intervention
Drug: responders
Drug: non-responders

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: Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype

Resource links provided by NLM:

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 ]

    antidepressant response is defined as the decrease rate of HAM-D score for 6week was = 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 ]

    Biological value is defined as

    1. Genetic information of bioamine transporter genes of patients. Measurement unit = if it is SNP,it is A, T, G, or C, and if VNTR, short or long allele


    2. Biological measure value of patients at 0 and 6week after antidepressant treatment(ex. peripheral markers such as serum BDNF, CREB...).

    Measurement unit = numerical value and thier unit such as O.D.(Optical Density)

Estimated Enrollment: 1000
Study Start Date: November 2001
Estimated Study Completion Date: December 2018
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: responders
50 ≤ Decrease rate(%) of HAM-D score
Drug: responders
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
nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score
Drug: non-responders
Antidepressants administration for 6 weeks under therapeutic dose
Other Name: SSRI nonresponders

Detailed Description:
The purpose of this study is to determine whether genomic effects or peripheral lymphatic biomarkers on antidepressant response differed by class of drug, whether genomic and biomarker differences between drug responders and nonresponders predict the response of antidepressant and to construct the prediction model for antidepressant treatment in order to aid to select the their genetically or endophenotypic matching drugs.

Ages Eligible for Study:   19 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT01352559

Korea, Republic of
Samsung Medical Center
Kangnam, Seoul, Korea, Republic of, 135-710
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., pHD, Samsung Medical Center Identifier: NCT01352559     History of Changes
Other Study ID Numbers: 2001-11-03
Study First Received: April 21, 2011
Last Updated: June 4, 2015
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Prediction of Antidepressant Response
Depressed Patients
Antidepressant Response
Adverse Reaction to Drug

Additional relevant MeSH terms:
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses processed this record on November 25, 2015