Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients - Full Text View

Sponsored by:	Samsung Medical Center
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT00817375

Purpose

The purpose of this study is to determine whether pharmacogenomic study predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration.

Condition	Intervention
Depression Antidepressant Response Adverse Event	Drug: SSRI class antidepressant Drug: non-SSRI class antidepressant

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pharmacogenomic Study to Predict Antidepressant Responsiveness in Depressed Patients

Resource links provided by NLM:

MedlinePlus related topics: Antidepressants Depression

Drug Information available for: Fluoxetine Fluoxetine hydrochloride Paroxetine Paroxetine hydrochloride Sertraline hydrochloride Sertraline Mirtazapine Venlafaxine Nortriptyline Venlafaxine hydrochloride Paroxetine Mesylate Nortriptyline hydrochloride

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Biological value at 0 and 6 weeks [ Time Frame: 6weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	February 2003
Estimated Study Completion Date:	March 2012
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
SSRI treated group: Experimental SSRI treated with fluoxetine, paroxetine, or sertraline	Drug: SSRI class antidepressant Antidepressant administration of SSRI class for 6 weeks under therapeutic dose
non-SSRI treated group: Active Comparator non-SSRI treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine	Drug: non-SSRI class antidepressant Antidepressant administration of non-SSRI class for 6 weeks under therapeutic dose

Detailed Description:

The purpose of this study is

to determine whether genomic effects on antidepressant response differed by class of drug,
whether genomic differences between drug responders and nonresponders predict the response of antidepressant

and
to construct the prediction model for antidepressant treatment in order to aid to select the their genetically matching drugs.

Eligibility

Ages Eligible for Study:	19 Years to 89 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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: NCT00817375

Contacts

Contact: JungShil Back, B/Sc.	82-2-3410-0946	jungshil.back@samsung.com
Contact: Shinn-Won Lim, M.Sc.	82-2-3410-3759	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 Kim 82-2-3410-2975 kggo.kim@samsung.com

Sponsors and Collaborators

Samsung Medical Center

Investigators

Principal Investigator:

Doh Kwan Kim, M.D., Ph.D.

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Samsung Medical Center ( Doh Kwan Kim, M.D., Ph.D. )
Study ID Numbers:	2003-01-12
Study First Received:	January 5, 2009
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00817375 History of Changes
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

Pharmacogenomics
Prediction of Antidepressant Response
Depressed Patients

Study placed in the following topic categories:

Depression
Psychotropic Drugs
Depressive Disorder
Mirtazapine
Paroxetine
Serotonin Uptake Inhibitors
Behavioral Symptoms

Fluoxetine
Milnacipran
Venlafaxine
Nortriptyline
Sertraline
Antidepressive Agents

Additional relevant MeSH terms:

Depression
Therapeutic Uses
Psychotropic Drugs
Central Nervous System Agents

Pharmacologic Actions
Antidepressive Agents
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 02, 2009