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Depression | Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MirtazapineMirtazapine administration for 6 weeks under therapeutic dose

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

RespondersReponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine

Non-respondersNon-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

Study Status

Recruiting

Start Date: February 2003

Completed Date: December 2018

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks

Secondary Outcome: Biological value at 0 and 6 weeks

Study sponsors, principal investigator, and references

Principal Investigator: Doh Kwan Kim, M.D., Ph.D.

Lead Sponsor: Samsung Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01039740

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