Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

Depression Clinical Trial

Official title:

Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01237275
• Other study ID #: 1999-10-14
• 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

• Adverse Reaction to Drug
• Continuous Antidepressant Abuse
• Depression
• Drug-Related Side Effects and Adverse Reactions

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