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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Primary Purpose

Depression

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Mirtazapine

About this trial

This is an interventional treatment trial for Depression focused on measuring Pharmacogenomics, Prediction of Mirtazapine response, Depressed patients, Mirtazapine response, Adverse event

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
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.

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Responders

Non-responders

Arm Description

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 is a patients group who did not show 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Biological value at 0 and 6 weeks

Full Information

NCT ID

NCT01039740

First Posted

December 23, 2009

Last Updated

December 30, 2015

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01039740

Brief Title

Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Official Title

Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2003 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Pharmacogenomics, Prediction of Mirtazapine response, Depressed patients, Mirtazapine response, Adverse event

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Responders

Arm Type

Experimental

Arm Description

Reponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine

Arm Title

Non-responders

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mirtazapine

Other Intervention Name(s)

Mirtazapine_Remeron, Avanza, Zispin

Intervention Description

Mirtazapine administration for 6 weeks under therapeutic dose

Primary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Biological value at 0 and 6 weeks

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians Exclusion Criteria: received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

JungShil Back, B/Sc.

Phone

82-2-3410-0946

junshil.back@sbri.co.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Shinn-won Lim, M.Sc.

Phone

82-2-3410-3759

shinwon.lim@sbri.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doh Kwan Kim, M.D., Ph.D.

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Kangnam

State/Province

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Samsung Medical Center Kim, phD, MD

Phone

82-2-3410-3582

dohkwan.kim@samsung.com

12. IPD Sharing Statement

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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

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