Back to resultsPrediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
responders
non-responders
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Pharmacogenomics, Prediction of Antidepressant Response, Depressed Patients, biomarkers, phenotype, Antidepressant Response, Adverse Reaction to Drug
Eligibility 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.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
responders
non-responders
Arm Description
50 ≤ Decrease rate(%) of HAM-D score
nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score
Outcomes
Primary Outcome Measures
Antidepressant Response at 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
Biological value at 0 and 6 weeks
Biological value is defined as
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
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)
Full Information
NCT ID
NCT01352559
First Posted
April 21, 2011
Last Updated
December 30, 2015
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01352559
Brief Title
Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype
Official Title
Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2001 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Pharmacogenomics, Prediction of Antidepressant Response, Depressed Patients, biomarkers, phenotype, Antidepressant Response, Adverse Reaction to Drug
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
responders
Arm Type
Experimental
Arm Description
50 ≤ Decrease rate(%) of HAM-D score
Arm Title
non-responders
Arm Type
Active Comparator
Arm Description
nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score
Intervention Type
Drug
Intervention Name(s)
responders
Other Intervention Name(s)
fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, milnacipran, venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron
Intervention Description
Antidepressants administration for 6 weeks under therapeutic dose
Intervention Type
Drug
Intervention Name(s)
non-responders
Other Intervention Name(s)
SSRI nonresponders
Intervention Description
Antidepressants administration for 6 weeks under therapeutic dose
Primary Outcome Measure Information:
Title
Antidepressant Response at 6 weeks
Description
antidepressant response is defined as the decrease rate of HAM-D score for 6week was = or > 50%
Measurement Unit = responders, nonresponders
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Biological value at 0 and 6 weeks
Description
Biological value is defined as
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
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)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doh Kwan Kim, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Kangnam
State/Province
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
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Prediction of Antidepressant Response Using Pharmacogenetics and Peripheral Lymphocytic Phenotype
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