NCT01997580
Unknown
Phase 4
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
Overview
- Phase
- Phase 4
- Intervention
- escitalopram
- Conditions
- Major Depressive Disorder
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
- Last Updated
- 12 years ago
Overview
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
Investigators
Jae Seung Chang
Associate Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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
Arms & Interventions
Escitalopram
depressed patients receiving escitalopram treatment
Intervention: escitalopram
Outcomes
Primary Outcomes
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
Time Frame: 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 Outcomes
- Change in cardiorespiratory coupling during 6 weeks(0, 3, 7, 14, and 42 days)
- Change in persistent homology during 6 weeks(0, 3, 7, 14, and 42 days)
- Change in HF during 6 weeks(0, 3, 7, 14, and 42 days)
Study Sites (1)
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