Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-12 @ 12:15 PM
Study NCT ID:
NCT01754532
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '10mg of posterior vertex hair'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-18', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Positive And Negative Symptoms Score', 'timeFrame': '3 month', 'description': 'correlation between hair cortisol level change from baseline and PANSS score change from baseline.'}, {'measure': 'Change from Baseline in Positive And Negative Symptoms Score', 'timeFrame': '6 month', 'description': 'correlation between hair cortisol level change from baseline and PANSS score change from baseline.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores', 'timeFrame': '3 month', 'description': 'correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.'}, {'measure': 'Change from Baseline in SANS, CGI, CDS, GAF and QOL Scores', 'timeFrame': '6 month', 'description': 'correlation between hair cortisol level change from baseline and SANS, CDS, GAF, CGI, and QOL scores change from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Schizo-Affective Disorder', 'Stress', 'Cortisol', 'PANSS'], 'conditions': ['Schizophrenia', 'Schizo-Affective Disorder']}, 'descriptionModule': {'briefSummary': 'The importance of stress as a possible deteriorating factor for schizophrenic patients is well documented. However, this notion is based on subjective experience and retrospective psychological analysis.\n\nA novel method of measuring cortisol using hair has a proven correlation to subjective stress in non-clinical as well as psychiatric clinical populations.\n\nThis pilot study will attempt to assess the use of cortisol hair level, as a marker of stress, to predict clinical deterioration in schizophrenic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Schizophrenia or Schizo-Affective Disorder', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-50\n* Diagnosis of schizophrenia or schizoaffective disorder, made by a senior psychiatrist.\n* Signing an informed consent.\n\nExclusion Criteria:\n\n* Additional psychiatric diagnosis\n* Boldness or hair shorter than 1cm\n* Physiological disturbance in the HPA or the use of steroidal medication\n* Neurological disease (past or present) or neurosurgery.\n* Pregnancy\n* Substantial chronic physical diseases/'}, 'identificationModule': {'nctId': 'NCT01754532', 'briefTitle': 'Correlation Between Clinical Deterioration in Schizophrenic Patients and Hair Cortisol Levels', 'organization': {'class': 'OTHER', 'fullName': 'Shalvata Mental Health Center'}, 'orgStudyIdInfo': {'id': 'SHA-12-0028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Schizophrenia patients', 'interventionNames': ['Biological: Hair Sample']}], 'interventions': [{'name': 'Hair Sample', 'type': 'BIOLOGICAL', 'description': 'Analysis of hair cortisol levels', 'armGroupLabels': ['Schizophrenia patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hod HaSharon', 'country': 'Israel', 'facility': 'Shalvata MHC', 'geoPoint': {'lat': 32.15934, 'lon': 34.8932}}], 'overallOfficials': [{'name': 'Aviv Segev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shalvata MHC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shalvata Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Aviv Segev', 'investigatorAffiliation': 'Shalvata Mental Health Center'}}}}