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Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

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. Read our disclaimer for details. Identifier: NCT00817011
Recruitment Status : Unknown
Verified December 2015 by Doh Kwan Kim, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : January 6, 2009
Last Update Posted : December 31, 2015
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Depression Antidepressant Drug Adverse Reaction Drug: SSRI treated group Drug: non-SSRI treated group Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness
Study Start Date : April 2006
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: SSRI treated group
SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline
Drug: SSRI treated group
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
Other Names:
  • Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
  • citalopram_Celexa

Active Comparator: non-SSRI treated group
non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
Drug: non-SSRI treated group
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
Other Names:
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron
  • bupropion_amfebutamone, Wellbutrin, Zyban
  • duloxetine_Cymbalta, Yentreve
  • trazodone_Desyrel, Beneficat, Deprax

Primary Outcome Measures :
  1. all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ]

Secondary Outcome Measures :
  1. all clinical cause drug response [ Time Frame: 24weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00817011

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Contact: Doh Kwan Kim, M.D.,Ph.D 82-2-3410-0946
Contact: Shinn-Won Lim, phD 82-2-3410-3759

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Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of, 135-710
Contact: DohKwan Kim         
Principal Investigator: Doh Kwan Kim, ph.D, M.D.         
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Doh Kwan Kim, M.D.,Ph.D. Samsung Medical Center

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Responsible Party: Doh Kwan Kim, M.D., Ph.D, Samsung Medical Center Identifier: NCT00817011     History of Changes
Other Study ID Numbers: 2006-03-012
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015
Keywords provided by Doh Kwan Kim, Samsung Medical Center:
antidepressant response
biological markers
clinical variables
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Behavioral Symptoms
Chemically-Induced Disorders
Duloxetine Hydrochloride
Antidepressive Agents
Venlafaxine Hydrochloride
Psychotropic Drugs
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Sensory System Agents