Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2026-01-27 @ 5:33 PM
Study NCT ID:
NCT01583569
Status:
COMPLETED
Last Update Posted:
2015-10-07
First Post:
2012-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complex Dynamic Systems in Mood Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2012-03-30', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Complex Dynamic Systems', 'Biomarkers', 'Mood Disorders'], 'conditions': ['Bipolar Disorder', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Complex Dynamic Systems in Mood Disorders is an observational, exploratory study of the relationship between voice samples, heart rate, respiration, movement, galvanic skin conductance, and sleep architecture with mood states in patients with Major Depressive Disorder, Bipolar Disorder, and healthy controls. The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability, movement, arousal, and sleep stage data.', 'detailedDescription': 'Aim 1: To assess multichannel physiologic measures associated with mood disorders.\n\nHypothesis: The overall hypothesis is that nonlinear dynamic analyses will be able to reveal hidden patterns of complexity in each domain of voice, heart rate variability (RR intervals), movement, arousal, and sleep stage data.\n\nAim 2: To assess differences in patterns and complexity of multiple physiological measures in patients with MDD compared to healthy controls.\n\nHypothesis: MDD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.\n\nAim 3: To assess differences in patterns and complexity of multiple physiologic measures in patients with BD compared to healthy controls.\n\nHypothesis: BD will be associated with decreased measures of complexity and increased measures of approximate entropy compared to healthy controls.\n\nAim 4: To assess changes in patterns and complexity of multiple physiologic measures at baseline and after 2 weeks of treatment for patients with MDD and BD.\n\nHypothesis: Measures of complexity will increase and measures of approximate entropy will decrease in the first two weeks of treatment.\n\nAim 5: To assess the relationship between changes in patterns and complexity of multiple physiologic measures and changes in mood state.\n\nHypothesis: Measures of complexity will increase and measures of approximate entropy will decrease, especially for those who are much or very much improved'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The sample will consist of subjects with Major Depressive Disorder(n=5), Bipolar Disorder (n=5), as well as healthy controls (n=5)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 and \\< 65.\n* Meet DSM-IV criteria for MDD (n=5), BD (n=5), or healthy controls with no psychiatric diagnosis (n=5).\n* Willing and able to wear a wearable device to measure sleep parameters\n* Willing and able to provide voice samples.\n* Subjects with MDD must not be taking psychiatric medications at the time of evaluation.Subjects with BD can be taking psychiatric medications, since it is not feasible for patients with BD to be completely free of mood stabilizing medications. These medications will be limited to lithium, second generation antipsychotics.\n* Currently a patient or research participant at the DCRP or the BCRP or are healthy controls enrolled in evaluation studies.\n\nExclusion Criteria:\n\n* Primary sleep disorder, including restless legs syndrome, difficulties in initiating and maintaining sleep.\n* Movement disorders (e.g. Parkinson's, Huntington's, tardive dyskinesia, primary chorea).\n* Active substance abuse or dependence in the past 3 months.\n* Cardiovascular or pulmonary disease, including uncontrolled hypertension, arrhythmias, history of myocardial infarction, asthma, COPD, or pulmonary carcinoma.\n* Cardiovascular or pulmonary medications (aspirin and statins are allowable).\n* Anticonvulsants.\n* Sedative/hypnotics (e.g. benzodiazepines, eczopiclone).\n* Smokers.\n* Pregnancy."}, 'identificationModule': {'nctId': 'NCT01583569', 'briefTitle': 'Complex Dynamic Systems in Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Complex Dynamic Systems in Mood Disorders', 'orgStudyIdInfo': {'id': '3273723'}, 'secondaryIdInfos': [{'id': '1K18MH093939-01', 'link': 'https://reporter.nih.gov/quickSearch/1K18MH093939-01', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02144', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Bipolar Clinic and Research Program at Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research, Bipolar Clinic and Research Program', 'investigatorFullName': 'Andrew A. Nierenberg, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}