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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

NCT ID: NCT01039740

Last Updated: 2015-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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Pharmacogenomics Prediction of Mirtazapine response Depressed patients Mirtazapine response Adverse event

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Responders

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

Group Type EXPERIMENTAL

Mirtazapine

Intervention Type DRUG

Mirtazapine administration for 6 weeks under therapeutic dose

Non-responders

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

Group Type EXPERIMENTAL

Mirtazapine

Intervention Type DRUG

Mirtazapine administration for 6 weeks under therapeutic dose

Interventions

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Mirtazapine

Mirtazapine administration for 6 weeks under therapeutic dose

Intervention Type DRUG

Other Intervention Names

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Mirtazapine_Remeron, Avanza, Zispin

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Doh Kwan Kim

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Kangnam, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JungShil Back, B/Sc.

Role: CONTACT

Phone: 82-2-3410-0946

Email: [email protected]

Shinn-won Lim, M.Sc.

Role: CONTACT

Phone: 82-2-3410-3759

Email: [email protected]

Facility Contacts

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Samsung Medical Center Kim, phD, MD

Role: primary

Other Identifiers

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2007-08-092

Identifier Type: -

Identifier Source: org_study_id