Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

NCT ID: NCT01272518

Last Updated: 2019-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mood Disorder Mania Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sao Jose do Rio Preto Medical School

OTHER

Sponsor Role lead

Responsible Party

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Guilherme Luiz

Guilherme Luiz Lopes Wazen

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guilherme L Wazen

Role: PRINCIPAL_INVESTIGATOR

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

Role: STUDY_DIRECTOR

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)

Locations

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São José do Rio Preto Faculty of Medicine

São José do Rio Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Guilherme L. Wazen, Psychiatrist

Role: CONTACT

055-17-9117-3927

Moacir F. Godoy, Professor

Role: CONTACT

055-17-97726901

Facility Contacts

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Guilherme L. Wazen, Psychiatrist

Role: primary

055-17-9117-3927

Moacir F. Godoy, Professor

Role: backup

055-17-97726901

References

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Gregorio ML, Wazen GLL, Kemp AH, Milan-Mattos JC, Porta A, Catai AM, de Godoy MF. Non-linear analysis of the heart rate variability in characterization of manic and euthymic phases of bipolar disorder. J Affect Disord. 2020 Oct 1;275:136-144. doi: 10.1016/j.jad.2020.07.012. Epub 2020 Jul 10.

Reference Type DERIVED
PMID: 32658816 (View on PubMed)

Other Identifiers

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sao jose RPU

Identifier Type: REGISTRY

Identifier Source: secondary_id

459/2010

Identifier Type: -

Identifier Source: org_study_id

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