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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01997580

Enrollment

600

Registered

2013-11-28

Start date

2013-07-31

Completion date

2018-12-31

Last updated

2013-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

depression, treatment, electrophysiology, biomarker

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

Interventions

DRUGescitalopram

SSRI antidepressant

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 HF during 6 weeks	0, 3, 7, 14, and 42 days	change in high frequency component of heart rate variability
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

Countries

South Korea

Contacts

Primary ContactJae Seung Chang, MD, PhD

cjs0107@gmail.com82-31-787-7437

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026