Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Not Applicable

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

• Registration Number: NCT00817011
• Lead Sponsor: Samsung Medical Center

Brief Summary

The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Detailed Description

The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects.

If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.

Study Timeline

• Study Start: 2006-04
• 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: 2016-12
• Study Completion: 2018-03

Recruitment & Eligibility

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

Inclusion Criteria

1. 25 < age <85
2. major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
3. 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
non-SSRI treated group	non-SSRI treated group	non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
SSRI treated group	SSRI treated group	SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline

Primary Outcome Measures

Name	Time	Method
all pharmacogenetic and biological marker variables cause drug response	24weeks

Secondary Outcome Measures

Name	Time	Method
all clinical cause drug response	24weeks

Trial Locations

Locations (1)

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