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Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

NCT ID: NCT00817375

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

1000 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 pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4\~6 weeks after drug administration.

Detailed Description

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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.

Conditions

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Depression Adverse Reaction to Drug

Keywords

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Pharmacogenomics Prediction of Antidepressant Response Depressed Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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SSRI treated group

SSRI treated group is depressive patients treated with fluoxetine, paroxetine, or sertraline

Group Type EXPERIMENTAL

SSRI treated group

Intervention Type DRUG

Antidepressant administration of SSRI class for 6 weeks under therapeutic dose

non-SSRI treated group

non-SSRI treated group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine

Group Type ACTIVE_COMPARATOR

non-SSRI treated group

Intervention Type DRUG

Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Interventions

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SSRI treated group

Antidepressant administration of SSRI class for 6 weeks under therapeutic dose

Intervention Type DRUG

non-SSRI treated group

Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Intervention Type DRUG

Other Intervention Names

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fluoxetine_Prozac paroxetine_Paxil, Seroxat sertraline_Zoloft milnacipran venlafaxine_Effexor nortriptyline_Aventyl, Pamelor, Noritren mirtazapine_Avanza, Zispin, Remeron

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

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Doh Kwan Kim

M.D., pHD

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, phD.

Role: CONTACT

Phone: 82-2-3410-3759

Email: [email protected]

Facility Contacts

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Samsung Medical Center Kim, MD.pHD

Role: primary

Other Identifiers

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2003-01-12

Identifier Type: -

Identifier Source: org_study_id