Clinical trial NCT01272518: Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders
Official title: Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mood Disorder
Mania
Depression
Keywords: chaos theory heart rate variability mania bipolar disorder
Lead sponsor: Sao Jose do Rio Preto Medical School
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 3 months (period between the first and the second assessments)
Secondary outcomes:
measure: Polar RS800CX hear-rate monitor; Kubios HRV version 2.0 software; Visual Recurrence Analysis software.
timeFrame: 3 months (period between the first and the second assessments)
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: São José do Rio Preto Faculty of Medicine
state: São Paulo
Study officials:
affiliation: São José do Rio Preto Faculty of Medicine (FAMERP) / Departament of Psychiatry - FAMERP / NUTECC (Nucleo Transdisciplinar para Estudo do Caos e da Complexidade)
name: Guilherme L Wazen
role: PRINCIPAL_INVESTIGATOR
affiliation: 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)
name: Moacir F Godoy, Professor
role: STUDY_DIRECTOR
References:
citation: 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.