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Predict Antidepressant Responsiveness Using Pharmacogenomics

Primary Purpose

Depression, Depressive Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SSRI treated group
non-SSRI treated group
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Pharmacogenomics, Depressed Patients

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.
  • 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 is patients treated with fluoxetine, paroxetine, or sertraline

non-SSRI treated group is patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine

Outcomes

Primary Outcome Measures

Presences of each individual symptom of depression at 1,2,4,6,12 weeks
17-items HAM-D scale was employed to measure depressive symptoms

Secondary Outcome Measures

Full Information

First Posted
October 24, 2010
Last Updated
December 30, 2015
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01228357
Brief Title
Predict Antidepressant Responsiveness Using Pharmacogenomics
Official Title
Predict Antidepressant Responsiveness Using Pharmacogenomics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 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 determine whether genetic information associated with individual depressive symptoms.
Detailed Description
The primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression. The Second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Symptoms
Keywords
Pharmacogenomics, Depressed Patients

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 is patients treated with fluoxetine, paroxetine, or sertraline
Arm Title
non-SSRI treated group
Arm Type
Active Comparator
Arm Description
non-SSRI treated group is patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine
Intervention Type
Drug
Intervention Name(s)
SSRI treated group
Other Intervention Name(s)
fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft
Intervention Description
Antidepressant administration of SSRI class for 12 weeks under therapeutic dose
Intervention Type
Drug
Intervention Name(s)
non-SSRI treated group
Other Intervention Name(s)
milnacipran, venlafaxine_Effexor, nortriptyline_Aventyl, Pamelor, Noritren, mirtazapine_Avanza, Zispin, Remeron
Intervention Description
Antidepressant administration of non-SSRI class for 12 weeks under therapeutic dose
Primary Outcome Measure Information:
Title
Presences of each individual symptom of depression at 1,2,4,6,12 weeks
Description
17-items HAM-D scale was employed to measure depressive symptoms
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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
JungShil Back, B/Sc.
Phone
82-2-3410-0946
Email
jungshil.back@sbri.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Shinn-Won Lim, phD
Phone
82-2-3410-3759
Email
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
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doh Kwan Kim, MD.PhD
Phone
82-2-3410-3582
Email
dohkwan.kim@samsung.com
First Name & Middle Initial & Last Name & Degree
Woojae Myung, MD.
Phone
82-2-3410-6562
Email
smbhealer@gmail.com

12. IPD Sharing Statement

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Predict Antidepressant Responsiveness Using Pharmacogenomics

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