Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

Depression Clinical Trial

Official title:

Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01272518
• Other study ID #: 459/2010
• Secondary ID: sao jose RPU
• Status: Recruiting
• Start date: January 2011
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Sao Jose do Rio Preto Medical School
• Contact: Guilherme L. Wazen, Psychiatrist
• Phone: 055-17-9117-3927
• Email: wazenguilherme[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Disease
• Mania
• Mood Disorder
• Mood Disorders

Locations

Country	Name	City	State
Brazil	São José do Rio Preto Faculty of Medicine	São José do Rio Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sao Jose do Rio Preto Medical School

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	3 months (period between the first and the second assessments)
Secondary	Polar RS800CX hear-rate monitor; Kubios HRV version 2.0 software; Visual Recurrence Analysis software.	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.	3 months (period between the first and the second assessments)