Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT00184418
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2005-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Immune System and Psychiatric Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, frozen'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2005-09-15', 'studyFirstSubmitQcDate': '2005-09-15', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cytokines', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunity', 'Immune System', 'Cytokines', 'Psychophysiology', 'Psychoneuroimmunology'], 'conditions': ['Stress Disorders, Traumatic', 'Depressive Disorder', 'Bipolar Disorder', 'Personality Disorders', 'Schizophrenia', 'Psychotic Disorders']}, 'referencesModule': {'references': [{'pmid': '27578448', 'type': 'RESULT', 'citation': 'Saether SG, Schou M, Stoecker W, Teegen B, Borowski K, Vaaler A, Kondziella D, Reitan SK. Onconeural Antibodies in Acute Psychiatric Inpatient Care. J Neuropsychiatry Clin Neurosci. 2017 Winter;29(1):74-76. doi: 10.1176/appi.neuropsych.16050110. Epub 2016 Aug 31.'}, {'pmid': '27609625', 'type': 'RESULT', 'citation': 'Schou M, Saether SG, Borowski K, Teegen B, Kondziella D, Stoecker W, Vaaler A, Reitan SK. Prevalence of serum anti-neuronal autoantibodies in patients admitted to acute psychiatric care. Psychol Med. 2016 Dec;46(16):3303-3313. doi: 10.1017/S0033291716002038. Epub 2016 Sep 9.'}, {'pmid': '30055589', 'type': 'DERIVED', 'citation': 'Sakai Y, Iversen V, Reitan SK. FT4 and TSH, relation to diagnoses in an unselected psychiatric acute-ward population, and change during acute psychiatric admission. BMC Psychiatry. 2018 Jul 28;18(1):244. doi: 10.1186/s12888-018-1819-3.'}]}, 'descriptionModule': {'briefSummary': 'The study is based on a hypothesis that there is interaction between the activity in the immune system and in the mind. To study this, the investigators register different measures for activity in the immune system on patients unselectedly admitted to an acute psychiatric ward. The psychiatric statuses and diagnoses of these patients are carefully defined as well.', 'detailedDescription': 'Our hypotheses are first that activity in the immune system influences the psychiatric status in general, second that changes in activity in psychiatric status affect activity in the immune system and third that there are connections between certain psychiatric conditions/disorders and certain features of the immune system.\n\nAll patients admitted to a psychiatric acute ward covering an area with a population of 130.000 and with around 1000 admittances to an acute psychiatric ward a year (some readmittances) are asked to participate in the study. Patients fill in a question form regarding psychiatric as well as somatic health with emphasis on diseases involving immune activity. When possible also slight information on the family is registered. Both at the time of admittance and after recovery clinical laboratory tests on somatic status are registered. In addition the level of different cytokines is measured. The psychiatric state and precise diagnoses are registered during the stay. The data will be analysed to uncover connections between psychiatric stress in general as well as specific psychiatric diagnoses and activity in the immune system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 18 years and above. Amitted to psychiatric acute ward of St Olavs Hospital, Trondheim, Norway.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to the adult acute psychiatric ward of a certain geographical area during the study period\n\nExclusion Criteria:\n\n* Patients that do not agree to participate in the study'}, 'identificationModule': {'nctId': 'NCT00184418', 'briefTitle': 'The Immune System and Psychiatric Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'The Immune System and Psychiatric Disorders', 'orgStudyIdInfo': {'id': '94463'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All patients admitted to a psychiatric acute ward'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-7040', 'city': 'Trondheim', 'state': 'Middle Norway', 'country': 'Norway', 'facility': 'St Olavs Hospital, Department of Psychiatry, Østmarka Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Solveig K Reitan, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'St Olavs Hospital/NTNU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}