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Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

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ClinicalTrials.gov Identifier: NCT00817011
Recruitment Status : Recruiting
First Posted : January 6, 2009
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Depression Antidepressant Drug Adverse Reaction Drug: SSRI treated group Drug: non-SSRI treated group

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.


Study Design

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
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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.
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): NCT00817011


Contacts
Contact: Doh Kwan Kim, M.D.,Ph.D 82-2-3410-0946 jungshil.back@sbri.co.kr
Contact: Shinn-Won Lim, phD 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: DohKwan Kim         
Principal Investigator: Doh Kwan Kim, ph.D, M.D.         
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: 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:
depression
pharmacogenomics
antidepressant response
biological markers
clinical variables

Additional relevant MeSH terms:
Depression
Drug-Related Side Effects and Adverse Reactions
Behavioral Symptoms
Chemically-Induced Disorders
Antidepressive Agents
Bupropion
Duloxetine Hydrochloride
Sertraline
Paroxetine
Fluoxetine
Venlafaxine Hydrochloride
Citalopram
Mirtazapine
Trazodone
Nortriptyline
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
Analgesics
Sensory System Agents