Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT01272518
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2011-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000087122', 'term': 'Mania'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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)', 'description': '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.'}], 'secondaryOutcomes': [{'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)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['chaos theory heart rate variability mania bipolar disorder'], 'conditions': ['Mood Disorder', 'Mania', 'Depression']}, 'referencesModule': {'references': [{'pmid': '32658816', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Acutely hospitalized patient and in ambulatorial attendance with Bipolar Disorder or Major Depressive Disorder.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)\n\nExclusion Criteria:\n\n* Another with criteria for Axis I or II disorders aside from the primary diagnosis of BD or MDD.\n* Past history of stroke, heart attack, or cardiac disease.\n* Drug abuse or dependence in the past six months.\n* Diabetes.\n* In use of Tricyclic Antidepressants'}, 'identificationModule': {'nctId': 'NCT01272518', 'briefTitle': 'Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Sao Jose do Rio Preto Medical School'}, 'officialTitle': 'Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory', 'orgStudyIdInfo': {'id': '459/2010'}, 'secondaryIdInfos': [{'id': 'sao jose RPU', 'type': 'REGISTRY', 'domain': '459/2010'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15090000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Guilherme L. Wazen, Psychiatrist', 'role': 'CONTACT', 'email': 'wazenguilherme@yahoo.com.br', 'phone': '055-17-9117-3927'}, {'name': 'Moacir F. Godoy, Professor', 'role': 'CONTACT', 'email': 'mf60204@gmail.com', 'phone': '055-17-97726901'}, {'name': 'Moacir F. Godoy, Professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'São José do Rio Preto Faculty of Medicine', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}], 'centralContacts': [{'name': 'Guilherme L. Wazen, Psychiatrist', 'role': 'CONTACT', 'email': 'wazenguilherme@yahoo.com.br', 'phone': '055-17-9117-3927'}, {'name': 'Moacir F. Godoy, Professor', 'role': 'CONTACT', 'email': 'mf60204@gmail.com', 'phone': '055-17-97726901'}], 'overallOfficials': [{'name': 'Guilherme L Wazen', 'role': 'PRINCIPAL_INVESTIGATOR', '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': 'Moacir F Godoy, Professor', 'role': 'STUDY_DIRECTOR', '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)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sao Jose do Rio Preto Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guilherme Luiz Lopes Wazen', 'investigatorFullName': 'Guilherme Luiz', 'investigatorAffiliation': 'Sao Jose do Rio Preto Medical School'}}}}