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Completed

NCT Number: NCT01455038

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Heart Rate Variability Mental Disorders Mood Disorders Subsyndromal Depressive Phase

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan medical center

Seoul, 138-736, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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.

Treatment and study plan

Primary outcomes

  1. Heart rate variability (HRV)

    Time frame: at baseline

    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)

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 19, 2011
Registry last updated
Oct 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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