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

Completed

• Conditions: Bipolar Disorder; Heart Rate Variability; Subsyndromal Depressive Phase

• Registration Number: NCT01455038
• Lead Sponsor: Asan Medical Center

Brief Summary

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

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-10
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-19
• Last Update Posted: 2011-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart rate variability (HRV)	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)

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, Korea, Republic of