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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Samsung Medical Center logo

Samsung Medical Center

Status

Unknown

Conditions

Depression

Treatments

Drug: Mirtazapine

Study type

Interventional

Funder types

Other

Identifiers

NCT01039740
2007-08-092

Details and patient eligibility

About

The purpose of this study is to determine whether pharmacogenetic study predict Mirtazapine responsiveness in advance before the appearance of the drug effect until 4-6 weeks after administration of Mirtazapine.

Full description

The purpose of this study is

  1. to determine whether genomic differences between drug responders and nonresponders predict the response of Mirtazapine and
  2. to construct the prediction model for Mirtazapine treatment in depressed patients in order to aid to select the genetically matching drug.

Enrollment

100 estimated patients

Sex

All

Ages

19 to 89 years old

Volunteers

No 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

Single Group Assignment

Masking

Single Blind

100 participants in 2 patient groups

Responders
Experimental group
Description:
Reponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
Treatment:
Drug: Mirtazapine
Non-responders
Experimental group
Description:
Non-responders is a patients group who did not show 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
Treatment:
Drug: Mirtazapine

Trial contacts and locations

1

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Central trial contact

Shinn-won Lim, M.Sc.; JungShil Back, B/Sc.

Data sourced from clinicaltrials.gov

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