Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

This study is currently recruiting participants.

Verified June 2012 by Samsung Medical Center

Sponsor:

Information provided by (Responsible Party):

Doh Kwan Kim, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01352572

First received: April 21, 2011

Last updated: June 29, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 21, 2011

Last Updated Date

June 29, 2012

Start Date ^ICMJE

January 2002

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Antidepressant Response at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50%

Measurement Unit = responders, nonresponders

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01352572 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte.

Measurement value : Optical Density(O.D), microgram/liter(ug/l)

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Official Title ^ICMJE

Effects of Antidepressant on Postsynaptic Signal Transduction in Serotonergic System of Depressed Patients

Brief Summary

The purpose of this study is to determine whether alteration of signal transduction components after antidepressant targeting, predict antidepressant responsiveness in advance before the appearance of the drug effects until 4~6 weeks after drug administration, or represent the clinical status of depressed patients.

Detailed Description

The purpose of this study is to determine whether antidepressants effect on signal transduction in peripheral lymphocyte and to determine whether the signaling differences between drug responders and nonresponders predict the antidepressant response or represent the clinical status of depressed patients.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

Drug: Antidepressants

Antidepressants administration for 6 weeks under therapeutic dose

Other Names:

fluoxetine_Prozac
paroxetine_Paxil, Seroxat
sertraline_Zoloft
milnacipran
venlafaxine_Effexor
nortriptyline_Aventyl, Pamelor, Noritren
mirtazapine_Avanza, Zispin, Remeron

Study Arm (s)

Experimental: responders
50 ≤ Decrease rate(%) of HAM-D score

Intervention: Drug: Antidepressants
Active Comparator: non-responders
50 > Decrease rate(%) of HAM-D score

Intervention: Drug: Antidepressants

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

December 2012

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

met the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-IV) criteria for MDD from the Department of Psychiatry, Sungkyunkwan University, Seoul, South Korea.
were 18 years of age or older, the existence of a unipolar major depressive episode as verified by DSM-III/IV criteria, at least 2 years after first episode onset, and agreement to informed consents

Exclusion Criteria:

pregnancy
significant medical conditions
abnormal laboratory baseline values
unstable psychiatric features (e.g, suicidal attempt)
history of alcohol or drug dependence, seizure, neurological illness, or concomitant Axis I psychiatric disorder

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jung Shil Beck, B Sc	82-2-3410-0946	jungshil.back@sbri.co.kr
Contact: Shinn-Won Lim, M Sc	82-2-3410-3759	shinwon.lim@sbri.co.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01352572

Other Study ID Numbers ^ICMJE

2002-09-08

Has Data Monitoring Committee

Yes

Responsible Party

Doh Kwan Kim, Samsung Medical Center

Study Sponsor ^ICMJE

Samsung Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Doh Kwan Kim, MD PhD

Samsung Medical Center

Information Provided By

Samsung Medical Center

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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