Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

Sponsor
Sao Jose do Rio Preto Medical School (Other)
Overall Status
Unknown status
CT.gov ID
NCT01272518
Collaborator
(none)
20
1
107
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    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
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Sep 1, 2019
    Anticipated Study Completion Date :
    Dec 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 São José do Rio Preto Faculty of Medicine São José do Rio Preto São Paulo Brazil 15090000

    Sponsors and Collaborators

    • Sao Jose do Rio Preto Medical School

    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)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guilherme Luiz, Guilherme Luiz Lopes Wazen, Sao Jose do Rio Preto Medical School
    ClinicalTrials.gov Identifier:
    NCT01272518
    Other Study ID Numbers:
    • 459/2010
    • sao jose RPU
    First Posted:
    Jan 7, 2011
    Last Update Posted:
    Sep 19, 2019
    Last Verified:
    Sep 1, 2019
    Keywords provided by Guilherme Luiz, Guilherme Luiz Lopes Wazen, Sao Jose do Rio Preto Medical School
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 19, 2019