Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype - Full Text View

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:

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.
interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
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

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
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Nortriptyline
Milnacipran
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Serotonin Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 23, 2013