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

This study has been completed.
Sponsor:
Collaborator:
Korean Health Technology R&D Project, Ministry of Health & Welfare
Information provided by (Responsible Party):
Yeon-Ho Joo, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01455038
First received: October 18, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  Purpose

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.


Condition
Bipolar Disorder
Subsyndromal Depressive Phase
Heart Rate Variability

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Heart rate variability (HRV) [ Time Frame: at baseline ] [ Designated as safety issue: No ]

    Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN).

    Frequency domain - TP (The variance of NN intervals over the temporal segment), VLF(Power in very low frequency range; <0.04 Hz), LF(Power in low frequency range; 0.04~0.15 Hz), HF(Power in high frequency range; 0.15~0.4 Hz)



Enrollment: 92
Study Start Date: January 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control group
Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Thirty three (10 males, 23 females) patients in clinically remitted state diagnosed with bipolar disorder based on DSM-IV criteria were enrolled at one outpatient psychiatric clinic and 59 healthy controls (23 males, 36 females) from health promotion center in a university-affiliated general hospital. We defined an individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale (MADRS) score of 10 or less and Clinical Global Impression severity (CGI-S) of 3 or less for last one month. Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01455038

Locations
Korea, Republic of
Asan medical center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Korean Health Technology R&D Project, Ministry of Health & Welfare
  More Information

No publications provided

Responsible Party: Yeon-Ho Joo, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01455038     History of Changes
Other Study ID Numbers: A090116
Study First Received: October 18, 2011
Last Updated: October 18, 2011
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014