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Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

Primary Purpose

Depression, Continuous Antidepressant Abuse, Adverse Reaction to Drug

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
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, Prediction of Antidepressant Response, 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 Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SSRI treated group

Arm Description

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

Outcomes

Primary Outcome Measures

Antidepressant Response at 2,4,6 weeks

Secondary Outcome Measures

Biological value at 0 and 6 weeks

Full Information

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

Unique Protocol Identification Number
NCT01237275
Brief Title
Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients
Official Title
Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 1999 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2016 (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
First, the investigators examined the functional relevance of serotonin transporter polymorphisms by quantifying the activity of serotonin transporter in blood platelets of genotyped healthy volunteers and patients with major depression. Second, the investigators studied response to SSRIs in relation to 5-HTTLPR genotype and also to the functional expression of 5-HTT in platelets.
Detailed Description
The purpose of this study is to determine whether serotonin transporter genotypic or functional differences between depressive patients and normal controls were existed. to determine the relationship between serotonin transporter polymorphisms and serotonin transporter functional expression. to determine whether genomic or functional differences between drug responders and nonresponders predict the response of antidepressant

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Continuous Antidepressant Abuse, Adverse Reaction to Drug
Keywords
Pharmacogenomics, Prediction of Antidepressant Response, Depressed Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
300 (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 or sertraline
Intervention Type
Drug
Intervention Name(s)
SSRI treated group
Other Intervention Name(s)
fluoxetine_Prozac, paroxetine_Paxil, Seroxat, sertraline_Zoloft
Intervention Description
characterize in arm of a study (SSRI treated group)
Primary Outcome Measure Information:
Title
Antidepressant Response at 2,4,6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Biological value at 0 and 6 weeks
Time Frame
6weeks

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.
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

12. IPD Sharing Statement

Learn more about this trial

Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

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