Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Doh Kwan Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00817011
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention
Depression
Antidepressant Drug Adverse Reaction
Drug: SSRI class antidepressant
Drug: non-SSRI class antidepressant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all clinical cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: April 2006
Estimated Study Completion Date: March 2015
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI treated group
SSRI treated with fluoxetine, paroxetine, citalopram or sertraline
Drug: SSRI class antidepressant
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 with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine
Drug: non-SSRI class antidepressant
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817011

Contacts
Contact: Doh Kwan Kim, M.D.,Ph.D 82-2-3410-0946 jungshil.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: 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

No publications provided

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
Study First Received: January 5, 2009
Last Updated: June 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
depression
pharmacogenomics
antidepressant response
biological markers
clinical variables

Additional relevant MeSH terms:
Depression
Depressive Disorder
Drug-Related Side Effects and Adverse Reactions
Behavioral Symptoms
Chemically-Induced Disorders
Mental Disorders
Mood Disorders
Antidepressive Agents
Nortriptyline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014