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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455038
• Other study ID #: A090116
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: October 18, 2011
• Start date: January 2010
• Est. completion date: April 2010

Study information

• Verified date: October 2011
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bipolar Disorder
• Heart Rate Variability
• Subsyndromal Depressive Phase

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Korean Health Technology R&D Project, Ministry of Health & Welfare

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability (HRV)	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)	at baseline	No