Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

December 30, 2015 updated by: Doh Kwan Kim, Samsung Medical Center

Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all pharmacogenetic and biological marker variables cause drug response
Time Frame: 24weeks
24weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
all clinical cause drug response
Time Frame: 24weeks
24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Doh Kwan Kim, M.D.,Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 30, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-03-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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