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Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

NCT ID: NCT00817011

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

2006-04-30

Study Completion Date

2018-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Depression Antidepressant Drug Adverse Reaction

Keywords

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depression pharmacogenomics antidepressant response biological markers clinical variables

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 are depressive patients treated with fluoxetine, paroxetine, citalopram 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 are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone 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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Other Names: fluoxetine_Prozac paroxetine_Paxil, Seroxat sertraline_Zoloft citalopram_Celexa venlafaxine_Effexor nortriptyline_Aventyl, Pamelor, Noritren mirtazapine_Avanza, Zispin, Remeron bupropion_amfebutamone, Wellbutrin, Zyban duloxetine_Cymbalta, Yentreve trazodone_Desyrel, Beneficat, Deprax

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

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

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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DohKwan Kim

Role: primary

Other Identifiers

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2006-03-012

Identifier Type: -

Identifier Source: org_study_id