Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Not Applicable

• Conditions: Depression
• Interventions: Drug: Mirtazapine

• Registration Number: NCT01039740
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

Detailed Description

The purpose of this study is

1. to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and

2. to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-25
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Responders	Mirtazapine	Reponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
Non-responders	Mirtazapine	Non-responders is a patients group who did not show 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine

Primary Outcome Measures

Name	Time	Method
Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks	6 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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