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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01237275
Other study ID # 1999-10-14
Secondary ID
Status Active, not recruiting
Phase N/A
First received November 1, 2010
Last updated December 30, 2015
Start date October 1999
Est. completion date December 2016

Study information

Verified date December 2015
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

The purpose of this study is

1. to determine whether serotonin transporter genotypic or functional differences between depressive patients and normal controls were existed.

2. to determine the relationship between serotonin transporter polymorphisms and serotonin transporter functional expression.

3. to determine whether genomic or functional differences between drug responders and nonresponders predict the response of antidepressant


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date December 2016
Est. primary completion date December 2003
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years to 89 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
SSRI treated group
characterize in arm of a study (SSRI treated group)

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Kangnam Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antidepressant Response at 2,4,6 weeks 6 weeks Yes
Secondary Biological value at 0 and 6 weeks 6weeks Yes
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