Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

• Conditions: Mood Disorder; Mania; Depression

• Registration Number: NCT01272518
• Lead Sponsor: Sao Jose do Rio Preto Medical School

Brief Summary

The purpose of this study is to characterize the behavior of cardiac patients with Mood Disorders and its clinical course, interpreting the results from a theoretical framework of Chaos Theory and Complexity Theory and Systems as well.

Detailed Description

Mood disorders are strongly associated with changes in cardiovascular function and alterations in Hear Rate Variability (HRV). Fluctuation in heart rate occurs over a wide frequency and demonstrates a broad, irregular variability that suggests that the mechanisms involved in cardiovascular regulation interact in a nonlinear manner. Over the past decade, there has been an increasing emphasis on applying nonlinear methods of analysis to characterize cardiac function, but the studies on the pathophysiology of mood disorders in general still remain under a linear and reductionist perspective. The scarcity of both Brazilian and international studies on the autonomic behavior in mood disorders in general and not only in Major Depressive Disorder, as well as the use of a non-linear reading of the results of this study makes an additional tool of analysis.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)

Exclusion Criteria

• Another with criteria for Axis I or II disorders aside from the primary diagnosis of BD or MDD.
• Past history of stroke, heart attack, or cardiac disease.
• Drug abuse or dependence in the past six months.
• Diabetes.
• In use of Tricyclic Antidepressants

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression(HAM-D-17)-17 ; Montgomery & Asberg Rating Scale for Depression(MADRS); Escala de Avaliação de Mania de Bech-Rafaelsen (EAM-BR); Mini International Neuropsychiatric Interview (MINI.	3 months (period between the first and the second assessments)	Both scales for depression and mania will be compared with the linear and nonlinear results from the heart rate variability in the period of 3 months.

Secondary Outcome Measures

Name	Time	Method
Polar RS800CX hear-rate monitor; Kubios HRV version 2.0 software; Visual Recurrence Analysis software.	3 months (period between the first and the second assessments)	The heart rate variability will be obtained from 20-min R to R wave (RR) interval data using the Polar. The data will be estimated by analysis from both softwares.

Trial Locations

Locations (1)

São José do Rio Preto Faculty of Medicine; 🇧🇷 São José do Rio Preto, São Paulo, Brazil