Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

NCT ID: NCT01455038

Last Updated: 2011-10-19

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

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.

Detailed Description

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Conditions

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Bipolar Disorder Subsyndromal Depressive Phase Heart Rate Variability

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control group

Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

No interventions assigned to this group

Bipolar group

individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale score of 10 or less and Clinical Global Impression severity of 3 or less for last one month.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Bipolar group:

* DSM-IV bipolar disorder
* Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10
* Clinical Global Impression severity (CGI-S) for last one month : ≤ 3
2. Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

Exclusion Criteria

* Psychiatric disorder except bipolar disorder
* Neurological symptoms or signs
* History of head trauma
* History of cardiovascular diseases
* Any medication except psychiatric medication.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Korean Health Technology R&D Project, Ministry of Health & Welfare

UNKNOWN

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yeon-Ho Joo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A090116

Identifier Type: -

Identifier Source: org_study_id