Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders

NCT01272518 | Unknown DMC

• 2 other identifiers: 459/2010sao jose RPU
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Mood Disorder; Mania; Depression

Keywords

chaos theory heart rate variability mania bipolar disorder

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (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)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sao Jose do Rio Preto Medical School: lead

Study Sites (1)

São José do Rio Preto Faculty of Medicine

São José do Rio Preto, São Paulo, 15090000, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 32658816 DERIVED

MeSH Terms

Conditions

Mood Disorders; Mania; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Guilherme L. Wazen, Psychiatrist

CONTACT

055-17-9117-3927; wazenguilherme@yahoo.com.br

Moacir F. Godoy, Professor

CONTACT

055-17-97726901; mf60204@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guilherme Luiz Lopes Wazen

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

BR (1)