Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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 Locations

  • Korea, Republic of
    • Seoul
      • Kangnam, Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Samsung Medical Center
        • Contact:

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

19 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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 is depressive patients treated with fluoxetine, paroxetine, or sertraline
Drug: SSRI treated group
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 group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine
Drug: non-SSRI treated group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antidepressant Response at 2,4,6 weeks A/E monitoring at 1,2,4,6 weeks
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Biological value at 0 and 6 weeks
Time Frame: 6weeks
6weeks

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

February 1, 2003

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 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

  • 2003-01-12

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.

Subscribe