Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01352559
Recruitment Status : Unknown
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : May 12, 2011
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Depression Drug: responders Drug: non-responders Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype
Study Start Date : November 2001
Actual Primary Completion Date : March 2007
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Antidepressant Response at 6 weeks [ Time Frame: 6 weeks ]

    antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or > 50%

    Measurement Unit = responders, nonresponders

Secondary Outcome Measures :
  1. Biological value at 0 and 6 weeks [ Time Frame: 6 weeks ]

    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)

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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Doh Kwan Kim, M.D., pHD, Samsung Medical Center Identifier: NCT01352559     History of Changes
Other Study ID Numbers: 2001-11-03
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

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

Additional relevant MeSH terms:
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Tricyclic
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs