This trial is active, not recruiting.

Condition depression
Treatments responders, non-responders
Sponsor Samsung Medical Center
Start date November 2001
End date March 2007
Trial size 1000 participants
Trial identifier NCT01352559, 2001-11-03


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
50 ≤ Decrease rate(%) of HAM-D score
responders fluoxetine_Prozac
Antidepressants administration for 6 weeks under therapeutic dose
(Active Comparator)
nonresponders is a patients having 50 > Decrease rate(%) of HAM-D score
non-responders SSRI nonresponders
Antidepressants administration for 6 weeks under therapeutic dose

Primary Outcomes

Antidepressant Response at 6 weeks
time frame: 6 weeks

Secondary Outcomes

Biological value at 0 and 6 weeks
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 19 years up to 89 years old.

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.

Additional Information

Official title Prediction of Antidepressant Response Using Pharmacogenetics of Bioamine Transporter and Peripheral Lymphocytic Phenotype
Principal investigator Doh Kwan Kim, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Samsung Medical Center.