Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype

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
Sponsor:
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01352559
First received: April 21, 2011
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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
Depression
Drug: antidepressants

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

      or

    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: March 2013
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: antidepressants
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
50 > Decrease rate(%) of HAM-D score
Drug: antidepressants
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

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.

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352559

Contacts
Contact: JungShil Back, B/Sc 82-2-3410-0946 jungshil.back@sbri.co.kr
Contact: Shinn-Won Lim, M.Sc. 82-2-3410-3759 shinwon.lim@sbri.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of, 135-710
Contact: Doh Kwan Kim, MD pHD    82-2-3410-3582    dohkwan.kim@samsung.com   
Contact: Samsung Medical Center IRB    82-2-3410-2971    hj0503.lee@samsung.com   
Principal Investigator: Doh Kwan Kim, MD pHD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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
ClinicalTrials.gov Identifier: NCT01352559     History of Changes
Other Study ID Numbers: 2001-11-03
Study First Received: April 21, 2011
Last Updated: June 29, 2012
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 29, 2014