Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Depression Clinical Trial

— PG  

Official title:

Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00817011
• Other study ID #: 2006-03-012
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2009
• Last updated: December 30, 2015
• Start date: April 2006
• Est. completion date: March 2018

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: Doh Kwan Kim, M.D.,Ph.D
• 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 predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Description:

The difficulties to treat depressed patients are 1)the patients don't respond to antidepressant is about 40% of which, and 2) The time lag is existed until the patients respond to antidepressant and show the treatment effects.

If it is predicted the response of antidepressant in advance, it would be overcome such problems. Drug response generally is known to be related to the individual genetic information and the environmental factors. We are going to investigation about antidepressant response using these approaches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 25 < age <85

2. major depressed patients satisfied with the diagnosis criteria depression of DSM-IV

3. interview with one more patient's family member for objective diagnosis and final diagnosis decision by agreements of two more psychiatric physicians

Exclusion Criteria:

1. received psychotropic medication within 2 weeks of the study or fluoxetine within 4 weeks

2. 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

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

Intervention

Drug:
• SSRI treated group
Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
• non-SSRI treated group
Antidepressant administration of non-SSRI class for 6 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	all pharmacogenetic and biological marker variables cause drug response		24weeks	Yes
Secondary	all clinical cause drug response		24weeks	Yes