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

Primary Purpose

Major Depressive Disorder

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
escitalopram
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depressive Disorder focused on measuring depression, treatment, electrophysiology, biomarker

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Escitalopram

Control

Arm Description

depressed patients receiving escitalopram treatment

healthy controls matched for age, gender, and BMI

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in cardiorespiratory coupling during 6 weeks
change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration
Change in HF during 6 weeks
change in high frequency component of heart rate variability
Change in persistent homology during 6 weeks
change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks

Full Information

First Posted
November 19, 2013
Last Updated
November 22, 2013
Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01997580
Brief Title
Electrophysiologic Parameters and Biomarkers Predicting Treatment Response in Patients With Major Depressive Disorder
Official Title
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Ministry of Health & Welfare, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, treatment, electrophysiology, biomarker

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
depressed patients receiving escitalopram treatment
Arm Title
Control
Arm Type
No Intervention
Arm Description
healthy controls matched for age, gender, and BMI
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
lexapro
Intervention Description
SSRI antidepressant
Primary Outcome Measure Information:
Title
Change in baseline frequency of maximum of cross-spectrum during 6 weeks (Hz)
Description
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
Time Frame
0, 3, 7, 14, and 42 days
Secondary Outcome Measure Information:
Title
Change in cardiorespiratory coupling during 6 weeks
Description
change in value of cross-sample entropy measured by combining sample entropies of heart rate and respiration
Time Frame
0, 3, 7, 14, and 42 days
Title
Change in HF during 6 weeks
Description
change in high frequency component of heart rate variability
Time Frame
0, 3, 7, 14, and 42 days
Title
Change in persistent homology during 6 weeks
Description
change in disconnection pattern of EEG channel activities measured by Euclidean distance during 6 weeks
Time Frame
0, 3, 7, 14, and 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Seung Chang, MD, PhD
Phone
82-31-787-7437
Email
cjs0107@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Seung Chang, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Seung Chang, MD, PhD
Phone
82-31-787-7437
Email
cjs0107@gmail.com
First Name & Middle Initial & Last Name & Degree
Meerae Lim, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22408133
Citation
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.
Results Reference
background
Links:
URL
http://www.nlm.nih.gov/medlineplus/ency/article/000945.htm
Description
health information about depression

Learn more about this trial

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

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