Mood DisorderNCT01272518
Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders
An observational study of Mood Disorder and Mania, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mood Disorder, Mania, Depression
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.
Who may be able to join
- Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
São José do Rio Preto Faculty of Medicine
São José do Rio Preto, São Paulo, 15090000
Guilherme L. Wazen, Psychiatrist, 055-17-9117-3927, wazenguilherme@yahoo.com.br
Moacir F. Godoy, Professor, 055-17-97726901, mf60204@gmail.com
About this study
Official title: Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory
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.
Read the 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.
- Conditions
- Mood Disorder, Mania, Depression
- Keywords
- chaos theory heart rate variability mania bipolar disorder
- Medical subject headings
- Mood Disorders, Mania, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 3 months (period between the first and the second assessments)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sao Jose do Rio Preto Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Luiz, Sao Jose do Rio Preto Medical School
- Investigators
- Guilherme L Wazen, 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, 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272518
- Sponsor's protocol ID
- 459/2010
- Other IDs
- sao jose RPU
- Status last verified
- Sep 2019
- First submitted
- 6 Jan 2011
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32658816
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory
- ClinicalTrials.gov ID
- NCT01272518
- Acronym / sponsor ID
- 459/2010
- Conditions
- Mood Disorder, Mania, Depression
- Keywords
- chaos theory heart rate variability mania bipolar disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sao Jose do Rio Preto Medical SchoolUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.
Key inclusion criteria (1 listed)
- Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 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.
1 secondary outcome
Polar RS800CX hear-rate monitor; Kubios HRV version 2.0 software; Visual Recurrence Analysis software.
Time frame: 3 months (period between the first and the second assessments)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 32658816Gregorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme L Wazen 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 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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorder and Mania, run by Sao Jose do Rio Preto Medical School at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilherme L. Wazen, Psychiatrist (055-17-9117-3927, wazenguilherme@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 months (period between the first and the second assessments)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01272518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.