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Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

NCT ID: NCT01237275

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

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-10-31

Study Completion Date

2016-12-31

Brief Summary

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First, the investigators examined the functional relevance of serotonin transporter polymorphisms by quantifying the activity of serotonin transporter in blood platelets of genotyped healthy volunteers and patients with major depression.

Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also to the functional expression of 5-HTT in platelets.

Detailed Description

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The purpose of this study is

1. to determine whether serotonin transporter genotypic or functional differences between depressive patients and normal controls were existed.
2. to determine the relationship between serotonin transporter polymorphisms and serotonin transporter functional expression.
3. to determine whether genomic or functional differences between drug responders and nonresponders predict the response of antidepressant

Conditions

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Depression Continuous Antidepressant Abuse Adverse Reaction to Drug

Keywords

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Pharmacogenomics Prediction of Antidepressant Response Depressed Patients

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 or sertraline

Group Type EXPERIMENTAL

SSRI treated group

Intervention Type DRUG

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Interventions

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SSRI treated group

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Intervention Type DRUG

Other Intervention Names

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fluoxetine_Prozac paroxetine_Paxil, Seroxat sertraline_Zoloft

Eligibility Criteria

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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.
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.,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

Countries

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South Korea

Other Identifiers

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1999-10-14

Identifier Type: -

Identifier Source: org_study_id