Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
1 other identifier
interventional
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 major-depressive-disorder
Started Jul 2013
Longer than P75 for phase_4 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 28, 2013
November 1, 2013
3.4 years
November 19, 2013
November 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
Change in cardiorespiratory coupling during 6 weeks
0, 3, 7, 14, and 42 days
Change in HF during 6 weeks
0, 3, 7, 14, and 42 days
Change in persistent homology during 6 weeks
0, 3, 7, 14, and 42 days
Study Arms (2)
Escitalopram
EXPERIMENTALdepressed patients receiving escitalopram treatment
Control
NO INTERVENTIONhealthy controls matched for age, gender, and BMI
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV-TR major depressive disorder
- aged between 20 and 80
- durg-naive or drug-free
You may not qualify if:
- DSM-IV-TR substance-related disorders (except nicotine)
- significant medical or neurological conditions
- mental retardation or organic brain damage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related 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.
PMID: 22408133BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jae Seung Chang, MD, PhD
Seoul National University Bundang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 28, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2018
Last Updated
November 28, 2013
Record last verified: 2013-11