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Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness (PG)

Primary Purpose

Depression, Antidepressant Drug Adverse Reaction

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

SSRI treated group

non-SSRI treated group

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, pharmacogenomics, antidepressant response, biological markers, clinical variables

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

25 < age <85
major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks
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.

Sites / Locations

Samsung Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SSRI treated group

non-SSRI treated group

Arm Description

SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline

non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine

Outcomes

Primary Outcome Measures

all pharmacogenetic and biological marker variables cause drug response

Secondary Outcome Measures

all clinical cause drug response

Full Information

NCT ID

NCT00817011

First Posted

January 5, 2009

Last Updated

December 30, 2015

Sponsor

Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00817011

Brief Title

Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Acronym

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2006 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Antidepressant Drug Adverse Reaction

Keywords

depression, pharmacogenomics, antidepressant response, biological markers, clinical variables

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SSRI treated group

Arm Type

Experimental

Arm Description

SSRI treated group are depressive patients treated with fluoxetine, paroxetine, citalopram or sertraline

Arm Title

non-SSRI treated group

Arm Type

Active Comparator

Arm Description

non-SSRI treated group are depressive patients treated with venlafaxine, nortriptyline, bupropion, duloxetine, trazodone or mirtazapine

Intervention Type

Drug

Intervention Name(s)

SSRI treated group

Other Intervention Name(s)

Other Names:, fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft, citalopram_Celexa

Intervention Description

Antidepressant administration of SSRI class for 6 weeks under therapeutic dose

Intervention Type

Drug

Intervention Name(s)

non-SSRI treated group

Other Intervention Name(s)

venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron, bupropion_amfebutamone, Wellbutrin, Zyban, duloxetine_Cymbalta, Yentreve, trazodone_Desyrel, Beneficat, Deprax

Intervention Description

Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Primary Outcome Measure Information:

Title

all pharmacogenetic and biological marker variables cause drug response

Time Frame

24weeks

Secondary Outcome Measure Information:

Title

all clinical cause drug response

Time Frame

24weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 25 < age <85 major depressed patients satisfied with the diagnosis criteria depression of DSM-IV interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians Exclusion Criteria: received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Doh Kwan Kim, M.D.,Ph.D

Phone

82-2-3410-0946

jungshil.back@sbri.co.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Shinn-Won Lim, phD

Phone

82-2-3410-3759

shinwon.lim@sbri.co.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Doh Kwan Kim, M.D.,Ph.D.

Organizational Affiliation

Samsung Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Kangnam

State/Province

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

DohKwan Kim

First Name & Middle Initial & Last Name & Degree

Doh Kwan Kim, ph.D, M.D.

12. IPD Sharing Statement

Learn more about this trial

Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

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