Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00817011

Purpose

The Purpose of this study is to predict antidepressant response in advance using pharmacogenomics and peripheral biological markers in depressed patients.

Condition	Intervention	Phase
Depression Antidepressant Response	Drug: fluoxetine, sertraline	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Double Blind (Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase 4 Study of Development of Pharmacogenomic Method to Predict Antidepressant Responsiveness

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Fluoxetine Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

all pharmacogenetic and biological marker variables cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

all clinical cause drug response [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2009
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Intervention Details:

SSRI response at 2,4,6,8,12,and 24 weeks

Detailed 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.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

25 < age <65
major depressed patients satisfied with the diagnosis criteria depression of DSM-IV
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00817011

Contacts

Contact: SamsungMC Lim

82-2-3410-3582

shinwon.lim@samsung.com

Locations

Korea, Republic of, Seoul
Samsung Medical Center	Recruiting
#50 Ilwon-Dong, Kangnam-Gu, Seoul, Korea, Republic of, 135-710
Contact: Samsung Medical Center 02-3410-3651, 3759 shinwon.lim@samsung.com
Principal Investigator: Doh Kwan Kim, ph.D, M.D.

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Samsung Medical Center

More Information

No publications provided

Study ID Numbers:	A060618, 2006_03_012
Study First Received:	January 5, 2009
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00817011 History of Changes
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

depression
pharmacogenomics
antidepressant response
biological markers
clinical variables

Study placed in the following topic categories:

Fluoxetine
Neurotransmitter Agents
Depression
Mental Disorders
Psychotropic Drugs
Mood Disorders

Sertraline
Depressive Disorder
Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents
Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions

Behavioral Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on September 02, 2009