Predict Antidepressant Responsiveness Using Pharmacogenomics

Depression Clinical Trial

Official title:

Predict Antidepressant Responsiveness Using Pharmacogenomics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01228357
• Other study ID #: 2003-08-07
• Status: Recruiting
• Phase: N/A
• First received: October 24, 2010
• Last updated: December 30, 2015
• Start date: February 2003
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: JungShil Back, B/Sc.
• Phone: 82-2-3410-0946
• Email: jungshil.back[@]sbri.co.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether genetic information associated with individual depressive symptoms.

Description:

The primary hypothesis is that the variations of the candidate genes are associated with individual symptoms in patients with depression.

The Second hypothesis is that patients with the associated genetic variation suffer longer from the associated symptom than the patients without the associated genetic variation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Drug:
• SSRI treated group
Antidepressant administration of SSRI class for 12 weeks under therapeutic dose
• non-SSRI treated group
Antidepressant administration of non-SSRI class for 12 weeks under therapeutic dose

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	Presences of each individual symptom of depression at 1,2,4,6,12 weeks	17-items HAM-D scale was employed to measure depressive symptoms	12 weeks	Yes