Pharmacogenetic Study of Mirtazapine Response in Depressed Patients
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Feb 2003
Longer than P75 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 23, 2009
CompletedFirst Posted
Study publicly available on registry
December 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedDecember 31, 2015
December 1, 2015
14.8 years
December 23, 2009
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks
6 weeks
Secondary Outcomes (1)
Biological value at 0 and 6 weeks
6 weeks
Study Arms (2)
Responders
EXPERIMENTALReponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
Non-responders
EXPERIMENTALNon-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
Interventions
Mirtazapine administration for 6 weeks under therapeutic dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Kangnam, Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doh Kwan Kim, M.D., Ph.D.
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D.
Study Record Dates
First Submitted
December 23, 2009
First Posted
December 25, 2009
Study Start
February 1, 2003
Primary Completion
December 1, 2017
Study Completion
December 1, 2018
Last Updated
December 31, 2015
Record last verified: 2015-12