Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

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:
NCT00817375
First received: January 5, 2009
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.


Condition Intervention
Depression
Adverse Reaction to Drug
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: Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Biological value at 0 and 6 weeks [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: February 2003
Estimated Study Completion Date: March 2015
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SSRI treated group
SSRI treated with fluoxetine, paroxetine, or sertraline
Drug: SSRI class antidepressant
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
Other Names:
  • fluoxetine_Prozac
  • paroxetine_Paxil, Seroxat
  • sertraline_Zoloft
Active Comparator: non-SSRI treated group
non-SSRI treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine
Drug: non-SSRI class antidepressant
Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose
Other Names:
  • milnacipran
  • venlafaxine_Effexor
  • nortriptyline_Aventyl, Pamelor, Noritren
  • mirtazapine_Avanza, Zispin, Remeron

Detailed Description:

The purpose of this study is

  1. to determine whether genomic effects on antidepressant response differed by class of drug,
  2. whether genomic differences between drug responders and nonresponders predict the response of antidepressant and
  3. to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.
  Eligibility

Ages Eligible for Study:   19 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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: NCT00817375

Contacts
Contact: JungShil Back, B/Sc. 82-2-3410-0946 jungshil.back@samsung.com
Contact: Shinn-Won Lim, M.Sc. 82-2-3410-3759 shinwon.lim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Kangnam, Seoul, Korea, Republic of, 135-710
Contact: Samsung Medical Center Kim, MD.pHD    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

No publications provided

Responsible Party: Doh Kwan Kim, M.D., pHD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00817375     History of Changes
Other Study ID Numbers: 2003-01-12
Study First Received: January 5, 2009
Last Updated: June 29, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Pharmacogenomics
Prediction of Antidepressant Response
Depressed Patients

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

ClinicalTrials.gov processed this record on August 27, 2014