Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder

Major Depressive Disorder Clinical Trial

Official title:

Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01997580
• Other study ID #: A121987
• Status: Recruiting
• Phase: Phase 4
• First received: November 19, 2013
• Last updated: November 22, 2013
• Start date: July 2013
• Est. completion date: December 2018

Study information

• Verified date: November 2013
• Source: Seoul National University Bundang Hospital
• Contact: Jae Seung Chang, MD, PhD
• Phone: 82-31-787-7437
• Email: cjs0107[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To explore electrophysiologic parameters and biomarkers predicting treatment response of patients with major depressive disorder To explore electrophysiologic parameters and biomarkers predicting suicide risk of patients with major depressive disorder

Description:

Case-control study Repeated measures design

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• DSM-IV-TR major depressive disorder

• aged between 20 and 80

• durg-naive or drug-free

Exclusion Criteria:

• DSM-IV-TR substance-related disorders (except nicotine)

• significant medical or neurological conditions

• mental retardation or organic brain damage

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• escitalopram
SSRI antidepressant

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Chang JS, Yoo CS, Yi SH, Her JY, Choi HM, Ha TH, Park T, Ha K. An integrative assessment of the psychophysiologic alterations in young women with recurrent major depressive disorder. Psychosom Med. 2012 Jun;74(5):495-500. doi: 10.1097/PSY.0b013e31824d0da0. Epub 2012 Mar 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)	the link between the normalized high frequency component of heart rate variability (HRV-HFnu) representing cardiac vagal modulation and frontal alpha power related to resting state	0, 3, 7, 14, and 42 days	Yes
Secondary	Change in cardiorespiratory coupling during 6 weeks	change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration	0, 3, 7, 14, and 42 days	No
Secondary	Change in HF during 6 weeks	change in high frequency component of heart rate variability	0, 3, 7, 14, and 42 days	No
Secondary	Change in persistent homology during 6 weeks	change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks	0, 3, 7, 14, and 42 days	No

External Links

•   health information about depression