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

Phase 4

• Conditions: Major Depressive Disorder
• Interventions: Drug: escitalopram

• Registration Number: NCT01997580
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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

Detailed Description

Case-control study Repeated measures design

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-11-22
• Last Update Submitted: 2013-11-22
• Study First Posted: 2013-11-28
• Last Update Posted: 2013-11-28
• Primary Completion: 2016-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Escitalopram	escitalopram	depressed patients receiving escitalopram treatment

Primary Outcome Measures

Name	Time	Method
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)	0, 3, 7, 14, and 42 days	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

Secondary Outcome Measures

Name	Time	Method
Change in cardiorespiratory coupling during 6 weeks	0, 3, 7, 14, and 42 days	change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration
Change in persistent homology during 6 weeks	0, 3, 7, 14, and 42 days	change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks
Change in HF during 6 weeks	0, 3, 7, 14, and 42 days	change in high frequency component of heart rate variability

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of