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Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

This study is currently recruiting participants.
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01039740
First Posted: December 25, 2009
Last Update Posted: December 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
  Purpose
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.

Condition Intervention
Depression Drug: Mirtazapine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Resource links provided by NLM:


Further study details as provided by Doh Kwan Kim, Samsung Medical Center:

Primary Outcome Measures:
  • Mirtazapine response at 2,4,6 weeks and adverse events (A/E) monitoring at 1,2,4,6 weeks [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Biological value at 0 and 6 weeks [ Time Frame: 6 weeks ]

Estimated Enrollment: 100
Study Start Date: February 2003
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Responders
Reponders is a patients group who showed 50% or greater decrease in the HAM-D score at 6 weeks after treating with mirtazapine
Drug: Mirtazapine
Mirtazapine administration for 6 weeks under therapeutic dose
Other Name: Mirtazapine_Remeron, Avanza, Zispin
Experimental: Non-responders
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
Drug: Mirtazapine
Mirtazapine administration for 6 weeks under therapeutic dose
Other Name: Mirtazapine_Remeron, Avanza, Zispin

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01039740


Contacts
Contact: JungShil Back, B/Sc. 82-2-3410-0946 junshil.back@sbri.co.kr
Contact: Shinn-won Lim, M.Sc. 82-2-3410-3759 shinwon.lim@sbri.co.kr

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of, 135-710
Contact: Samsung Medical Center Kim, phD, MD    82-2-3410-3582    dohkwan.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Doh Kwan Kim, M.D., Ph.D. Samsung Medical Center
  More Information

Responsible Party: Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01039740     History of Changes
Other Study ID Numbers: 2007-08-092
First Submitted: December 23, 2009
First Posted: December 25, 2009
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Doh Kwan Kim, Samsung Medical Center:
Pharmacogenomics
Prediction of Mirtazapine response
Depressed patients
Mirtazapine response
Adverse event

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Mirtazapine
Mianserin
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Serotonin Antagonists
Serotonin Agents
Antidepressive Agents, Second-Generation