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

November 22, 2013 updated by: Jae Seung Chang, Seoul National University Bundang Hospital

Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Case-control study Repeated measures design

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae Seung Chang, MD, PhD
  • Phone Number: 82-31-787-7437
  • Email: cjs0107@gmail.com

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Sub-Investigator:
          • Meerae Lim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Escitalopram
depressed patients receiving escitalopram treatment
Drug: escitalopram
SSRI antidepressant
Other Names:
  • lexapro
No Intervention: Control
healthy controls matched for age, gender, and BMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 3, 7, 14, and 42 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Ministry of Health & Welfare, Korea

Investigators

  • Principal Investigator: Jae Seung Chang, MD, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 19, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (Estimate)

November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 22, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A121987

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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