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

NCT ID: NCT01997580

Last Updated: 2013-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Case-control study Repeated measures design

Conditions

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Major Depressive Disorder

Keywords

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depression treatment electrophysiology biomarker

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Escitalopram

depressed patients receiving escitalopram treatment

Group Type EXPERIMENTAL

escitalopram

Intervention Type DRUG

SSRI antidepressant

Control

healthy controls matched for age, gender, and BMI

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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escitalopram

SSRI antidepressant

Intervention Type DRUG

Other Intervention Names

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lexapro

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae Seung Chang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jae Seung Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Seung Chang, MD, PhD

Role: CONTACT

Phone: 82-31-787-7437

Email: [email protected]

Facility Contacts

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Jae Seung Chang, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22408133 (View on PubMed)

Related Links

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Other Identifiers

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A121987

Identifier Type: -

Identifier Source: org_study_id