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

This study is currently recruiting participants.

Verified by Samsung Medical Center, July 2009

First Received: July 7, 2009 Last Updated: July 14, 2009 History of Changes

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 Event	Drug: Escitalopram

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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

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, Seoul
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:	Samsung Medical Center ( Doh Kwan Kim, M.D., Ph.D. )
Study ID Numbers:	2008-12-042
Study First Received:	July 7, 2009
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00935246 History of Changes
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:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Mental Disorders
Therapeutic Uses
Dexetimide
Antidepressive Agents, Second-Generation

Antidepressive Agents
Depression
Depressive Disorder
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010