Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning - Full Text View

Sponsor:	Samsung Medical Center
Collaborator:	H. Lundbeck A/S
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00935246

Purpose

To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning).

Condition	Intervention
Depression Antidepressant Response Adverse Reaction to Drug	Drug: Escitalopram

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Antidepressants Depression Nuclear Scans

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

antidepressant response at 2,4,6,8 weeks A/E monitoring at 1,2,4,6,8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

biological value at 0 week and 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	202
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Antidepressant treated group Antidepressant treated group: depressed patients treated with Escitalopram	Drug: Escitalopram Antidepressant administration of Escitalopram for 8 weeks under therapeutic dose Other Name: Escitalopram : Lexapro

Detailed Description:

The purposes of this study are:

To reveal the genetic determinants of the treatment outcome of escitalopram in depressed patients (by using candidate gene approach and whole genome scanning)
To improve the success rate of escitalopram treatment response for depressed patients

Eligibility

Ages Eligible for Study:	19 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00935246

Contacts

Contact: Doh Kwan Kim, PhD., M.D.	82-2-3410-3582	paulkim@skku.edu
Contact: Shinn-Won Lim, M.Sc.	82-2-3410-3759	shinwon.lim@sbri.co.kr

Locations

Korea, Republic of
Samsung Medical Center	Recruiting
#50 Ilwon-dong Kangnam-gu, Seoul, Korea, Republic of, 135-710
Contact: Daemyoung Cha 82-2-3410-2975 daemyoung.cha@samsung.com

Sponsors and Collaborators

Samsung Medical Center

H. Lundbeck A/S

Investigators

Principal Investigator:

Doh Kwan Kim, PhD, M.D.

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Doh Kwan Kim, M.D., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00935246 History of Changes
Other Study ID Numbers:	2008-12-042
Study First Received:	July 7, 2009
Last Updated:	April 21, 2011
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Genomic devices
Prediction of Escitalopram Response
Depressed Patients

Additional relevant MeSH terms:

Depression
Depressive Disorder
Drug Toxicity
Behavioral Symptoms
Mood Disorders
Mental Disorders
Poisoning
Substance-Related Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on February 09, 2012