Back to results

Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

Primary Purpose

Depression, Continuous Antidepressant Abuse, Adverse Reaction to Drug

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Escitalopram

About this trial

This is an interventional treatment trial for Depression focused on measuring Genomic devices, Prediction of Escitalopram Response, Depressed Patients

Eligibility Criteria

19 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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 2

Arm Type

Experimental

No Intervention

Arm Label

Antidepressant treated group

other antidepressant treated group

Arm Description

Antidepressant treated group: depressed patients treated with Escitalopram

other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram

Outcomes

Primary Outcome Measures

antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks

Secondary Outcome Measures

biological value at 0 week and 8 weeks

Full Information

NCT ID

NCT00935246

First Posted

July 7, 2009

Last Updated

December 30, 2015

Sponsor

Samsung Medical Center

Collaborators

H. Lundbeck A/S

1. Study Identification

Unique Protocol Identification Number

NCT00935246

Brief Title

Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

Official Title

Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2008 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Samsung Medical Center

Collaborators

H. Lundbeck A/S

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).

Detailed Description

The purposes of this study are: To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning) To improve the success rate of escitalopram treatment response for depressed patients

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

Genomic devices, Prediction of Escitalopram Response, Depressed Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Non-Randomized

Enrollment

202 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Antidepressant treated group

Arm Type

Experimental

Arm Description

Antidepressant treated group: depressed patients treated with Escitalopram

Arm Title

other antidepressant treated group

Arm Type

No Intervention

Arm Description

other Antidepressant treated group: depressed patients treated with other antidepressant without escitalopram

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Escitalopram : Lexapro

Intervention Description

Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose

Primary Outcome Measure Information:

Title

antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

biological value at 0 week and 8 weeks

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

89 Years

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, PhD, M.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

12. IPD Sharing Statement

Learn more about this trial

Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

We'll reach out to this number within 24 hrs