Development of A Technique to Predict Antidepressant Responsiveness in Depressive Patients

Not Applicable

• Conditions: Continuous Antidepressant Abuse; Depression; Adverse Reaction to Drug
• Interventions: Drug: SSRI treated group

• Registration Number: NCT01237275
• Lead Sponsor: Samsung Medical Center

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

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

Study Timeline

• Study Start: 1999-10
• Primary Completion: 2003-12
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-07
• Study First Posted: 2010-11-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Antidepressant Response at 2,4,6 weeks	6 weeks

Secondary Outcome Measures

Name	Time	Method
Biological value at 0 and 6 weeks	6weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Kangnam, Seoul, Korea, Republic of