Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Sao Jose do Rio Preto University
Sponsor:
Information provided by (Responsible Party):
Guilherme Luiz, Sao Jose do Rio Preto University
ClinicalTrials.gov Identifier:
NCT01272518
First received: January 6, 2011
Last updated: August 1, 2014
Last verified: August 2014
  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
Mania
Depression

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

Resource links provided by NLM:


Further study details as provided by Sao Jose do Rio Preto University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272518

Contacts
Contact: Guilherme L. Wazen, Psychiatrist 055-17-9117-3927 wazenguilherme@yahoo.com.br
Contact: Moacir F. Godoy, Professor 055-17-97726901 mf60204@gmail.com

Locations
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    wazenguilherme@yahoo.com.br   
Contact: Moacir F. Godoy, Professor    055-17-97726901    mf60204@gmail.com   
Sub-Investigator: Moacir F. Godoy, Professor         
Sponsors and Collaborators
Sao Jose do Rio Preto University
Investigators
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: August 1, 2014
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 mania bipolar disorder

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders
Affective Disorders, Psychotic

ClinicalTrials.gov processed this record on August 27, 2014