Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-29 @ 6:36 PM
Study NCT ID:
NCT02187835
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2014-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decreased EEG Complexity in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-08-04', 'releaseDate': '2014-07-10'}], 'estimatedResultsFirstSubmitDate': '2014-07-10'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-10', 'studyFirstSubmitDate': '2014-07-09', 'studyFirstSubmitQcDate': '2014-07-10', 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the mean of the average Logarithmic Energy Entropy values', 'timeFrame': 'one day'}], 'secondaryOutcomes': [{'measure': 'Hurst Exponent value', 'timeFrame': 'one day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['complexity', 'electroencephalogram', 'entropy', 'negative symptoms', 'schizophrenia.'], 'conditions': ['Electrophysiological Randomness', 'Entropy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.npistanbul.com', 'label': 'Neuropsychiatry Istanbul Hospital, Istanbul, Turkey'}]}, 'descriptionModule': {'briefSummary': 'Aim was to detect EEG complexity in a specific group of patients to contribute to the discussion whether schizophrenia is associated with increased or decreased complexity. We included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized that chronic residual schizophrenia is characterized by decreased complexity in EEG.', 'detailedDescription': 'Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte, NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to the international 10-20 system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'diagnosed with schizophrenia,', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosed with schizophrenia, residual subtype, by two senior psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition (DSM-IV) were recruited from Neuropsychiatry Istanbul Hospital Only patients scoring 4 or higher on the Clinical Global Impression Scale for Severity (CGI-S)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02187835', 'briefTitle': 'Decreased EEG Complexity in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Decreased EEG Complexity in Chronic Residual Schizophrenia', 'orgStudyIdInfo': {'id': 'GHS001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'schizophrenia', 'description': 'patients with a diagnosis of schizohrenia'}, {'label': 'control', 'description': 'healthy control group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34768', 'city': 'Istanbul', 'state': 'Umraniye', 'country': 'Turkey (Türkiye)', 'facility': 'Uskudar University, NPIstanbul hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Gokben Hizli Sayar', 'investigatorAffiliation': 'Uskudar University'}}}}