Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

Samsung Medical Center

Status: Unknown

Conditions: Adverse Reaction to Drug; Depression

Treatments: Drug: non-SSRI treated group; Drug: SSRI treated group

Study type: Interventional

Funder types: Other

Identifiers

NCT00817375

2003-01-12

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,000 participants in 2 patient groups

SSRI treated group

Experimental group

Description:

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

Treatment:

Drug: SSRI treated group

non-SSRI treated group

Active Comparator group

Description:

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

Treatment:

Drug: non-SSRI treated group