Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders
This study is currently recruiting participants.
Verified April 2013 by Sao Jose do Rio Preto University
Information provided by (Responsible Party):
Guilherme Luiz, Sao Jose do Rio Preto University
First received: January 6, 2011
Last updated: April 4, 2013
Last verified: April 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.
- Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)
- 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.
- In use of Tricyclic Antidepressants
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272518
|São José do Rio Preto Faculty of Medicine
|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 |
Sao Jose do Rio Preto University
||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)
||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)
No publications provided
||Guilherme Luiz, Guilherme Luiz Lopes Wazen, Sao Jose do Rio Preto University
History of Changes
|Other Study ID Numbers:
||459/2010, sao jose RPU
|Study First Received:
||January 6, 2011
||April 4, 2013
||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:
ClinicalTrials.gov processed this record on April 16, 2014