Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

Not Applicable

• Conditions: Depression; Adverse Reaction to Drug
• Interventions: Drug: SSRI treated group; Drug: non-SSRI treated group

• Registration Number: NCT00817375
• Lead Sponsor: Samsung Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSRI treated group	SSRI treated group	SSRI treated group is depressive patients treated with fluoxetine, paroxetine, or sertraline
non-SSRI treated group	non-SSRI treated group	non-SSRI treated group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine

Primary Outcome Measures

Name	Time	Method
Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks	6 weeks

Secondary Outcome Measures

Name	Time	Method
Biological value at 0 and 6 weeks	6weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Kangnam, Seoul, Korea, Republic of