Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

Samsung Medical Center

Status: Unknown

Conditions: Antidepressant Drug Adverse Reaction; Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00817011

2006-03-012

Details and patient eligibility

About

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

Full description

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 25 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

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 are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline

Treatment:

Drug: SSRI treated group

non-SSRI treated group

Active Comparator group

Description:

non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine

Treatment:

Drug: non-SSRI treated group