Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

Official Title: “Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients”

The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.

The purpose of this study is

1. to determine whether genomic effects on antidepressant response differed by class of drug,

2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and

3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.

Intervention(s) in this Clinical Trial

• Drug: SSRI class antidepressant
  • Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
• Drug: non-SSRI class antidepressant
  • Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: SSRI treated group
  • SSRI treated with fluoxetine, paroxetine, or sertraline
• Active Comparator: non-SSRI treated group
  • non-SSRI treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine

Primary Measures

• Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks
  • Time Frame: 6 weeks
    Safety Issue?: Yes

Secondary Measures

• Biological value at 0 and 6 weeks
  • Time Frame: 6weeks
    Safety Issue?: 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: 89 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Samsung Medical Center Other

Overall Clinical Trial Officials and Contacts

Doh Kwan Kim, M.D., Ph.D. Principal Investigator Samsung Medical Center  

Overall Contact: JungShil Back, B/Sc. 82-2-3410-0946 jungshil.back@samsung.com

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00817375

Study ID Number: 2003-01-12

ClinicalTrials.gov Identifier: NCT00817375

Health Authority: South Korea: Institutional Review Board