Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders
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Purpose
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.
| Condition |
|---|
|
Mood Disorder |
| Study Type: | Observational |
| 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | November 2013 (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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.
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
Contacts and Locations| Contact: Guilherme L. Wazen, Psychiatrist | 055-17-9117-3927 | gwazen@yahoo.com.br |
| Contact: Moacir F. Godoy, Professor | 055-17-97726901 | mf60204@gmail.com |
| Brazil | |
| 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 gwazen@yahoo.com.br | |
| Contact: Moacir F. Godoy, Professor 055-17-97726901 mf60204@gmail.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) |
More Information
No publications provided
| Responsible Party: | Guilherme Luiz, Guilherme Luiz Lopes Wazen, Sao Jose do Rio Preto University |
| ClinicalTrials.gov Identifier: | NCT01272518 History of Changes |
| Other Study ID Numbers: | 459/2010, sao jose RPU |
| Study First Received: | January 6, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Sao Jose do Rio Preto University:
|
mood disorder chaos theory heart rate variability |
Additional relevant MeSH terms:
|
Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 13, 2013