Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory|
- 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. [ Time Frame: 3 months (period between the first and the second assessments) ] [ Designated as safety issue: No ]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.
- Polar RS800CX hear-rate monitor; Kubios HRV version 2.0 software; Visual Recurrence Analysis software. [ Time Frame: 3 months (period between the first and the second assessments) ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272518
|Contact: Guilherme L. Wazen, Psychiatristfirstname.lastname@example.org|
|Contact: Moacir F. Godoy, Professoremail@example.com|
|São José do Rio Preto Faculty of Medicine||Recruiting|
|São José do Rio Preto, São Paulo, Brazil, 15090000|
|Contact: Guilherme L. Wazen, Psychiatrist 055-17-9117-3927 firstname.lastname@example.org|
|Contact: Moacir F. Godoy, Professor 055-17-97726901 email@example.com|
|Sub-Investigator: Moacir F. Godoy, Professor|
|Principal Investigator:||Guilherme L Wazen||São José do Rio Preto Faculty of Medicine (FAMERP) / Departament of Psychiatry - FAMERP / NUTECC (Nucleo Transdisciplinar para Estudo do Caos e da Complexidade)|
|Study Director:||Moacir F Godoy, Professor||São José do Rio Preto Faculty of Medicine (FAMERP) /Cardiology and Cardiovascular Surgery Department -FAMERP/ NUTECC (Nucleo Transdisciplinar para Estudo do Caos e da Complexidade)|