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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01352572
• Other study ID #: 2002-09-08
• Status: Active, not recruiting
• Phase: N/A
• First received: April 21, 2011
• Last updated: December 30, 2015
• Start date: January 2002
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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

Study Design

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

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• antidepressant response
Antidepressants administration for 6 weeks under therapeutic dose responders
• antidepressant non-response
Antidepressants administration for 6 weeks under therapeutic dose nonresponders

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Kangnam	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antidepressant Response at 6 weeks	Rsponse is defined as decrease rate of HAM-D score for 6week of treament is = or >50%; Measurement Unit = responders, nonresponders	6 weeks	Yes
Secondary	Biological value at 0 and 6 weeks	Biologial value is defined as protein expression value of signaling components in peripheral lymphocyte.; Measurement value : Optical Density(O.D), microgram/liter(ug/l)	6 weeks	Yes