Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-29 @ 11:30 AM
Study NCT ID:
NCT01858857
Status:
UNKNOWN
Last Update Posted:
2013-05-29
First Post:
2013-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Geriatric Psychiatry and Pharmacovigilance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011602', 'term': 'Psychophysiologic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-05-27', 'studyFirstSubmitDate': '2013-05-15', 'studyFirstSubmitQcDate': '2013-05-20', 'lastUpdatePostDateStruct': {'date': '2013-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment', 'timeFrame': 'Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge.'}], 'secondaryOutcomes': [{'measure': 'Assessment of cognitive functioning', 'timeFrame': 'At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).', 'description': 'Mini Mental State Exam'}, {'measure': 'Quality of life', 'timeFrame': 'At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).'}, {'measure': 'Adverse drug reactions', 'timeFrame': 'Patients will be monitored continuosly during the hospital stay (expected average of 4 weeks) and at follow-up, which is 2 weeks after discharge.'}, {'measure': 'Serum levels of substances', 'timeFrame': '1 day at occurence of SAE'}, {'measure': 'Electrocardiogram', 'timeFrame': 'At baseline visit and last visit, max. 3 days before discharge from the ward (expected average of hospital stay: 4 weeks).'}, {'measure': 'Medication intake', 'timeFrame': 'Patients medication intake 2 weeks before hospitalisation, continuosly during the hospital stay and at follow-up 2 weeks after discharge will be assessed (expected average of 8 weeks).', 'description': 'Before hospitalisation and after discharge by interview, during the hospital stay by patients chart.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['geriatric psychiatry', 'pharmacovigilance'], 'conditions': ['Dementia', 'Depression', 'Schizophrenia', 'Psychosomatic Disorders', 'Anxiety Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment.\n\nThe aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises.\n\nTo assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites.\n\nAt Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed.\n\nAfterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system.\n\nIn case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually.\n\n2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All inpatients meeting the Inclusion/Exclusion criteria, treated at one of the geriatric psychiatry study sites (one university hospital and four primary care clinics), should be screened.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 65+ years old\n2. Inpatients treated at one of the geriatric psychiatry study sites.\n3. Signed consent form ( Patient and/or legally authorized custodian)\n\nExclusion Criteria:\n\n1\\. Patients that are incapable to give their informed consent and are not under legally authorized custodianship.'}, 'identificationModule': {'nctId': 'NCT01858857', 'acronym': 'GAP', 'briefTitle': 'Geriatric Psychiatry and Pharmacovigilance', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Pharmacovigilance in Gerontopsychiatric Patients', 'orgStudyIdInfo': {'id': 'GAP2013'}, 'secondaryIdInfos': [{'id': 'V-15222/68605/2012-2015', 'type': 'OTHER_GRANT', 'domain': 'Federal Institute for Drugs and Medical Devices (BfArM)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Geriatric psychiatric in patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Beirich Susanne', 'role': 'CONTACT', 'email': 's.beirich@alexius.de'}, {'name': 'Hans Gutzmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Hedwigshöhe', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Brandenburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Felix Hohl-Radke, MD', 'role': 'CONTACT', 'phone': '+49 3381 782156'}, {'name': 'Felix Hohl-Radke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Fachklinikum Brandenburg', 'geoPoint': {'lat': 52.41667, 'lon': 12.55}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Petra Garlipp, MD', 'role': 'CONTACT', 'email': 'garlipp.petra@mh-hannover.de', 'phone': '+495115326559'}, {'name': 'Petra Garlipp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hannover Medical School', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Lubin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Kropp Stefan, MD', 'role': 'CONTACT', 'phone': '+49 3546 29200'}, {'name': 'Stefan Kropp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Fachklinikum Lübben', 'geoPoint': {'lat': 51.93814, 'lon': 13.88826}}, {'city': 'Teupitz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Stefan Kropp', 'role': 'CONTACT', 'phone': '+4933766660'}, {'name': 'Stefan Kropp, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Asklepios Fachklinikum Teupitz', 'geoPoint': {'lat': 52.12967, 'lon': 13.6196}}], 'centralContacts': [{'name': 'Alexandra Kleimann, MD', 'role': 'CONTACT', 'email': 'gap_study@mh-hannover.de', 'phone': '+495115326559'}], 'overallOfficials': [{'name': 'Helge Frieling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MHH'}, {'name': 'Sermin Toto, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MHH'}, {'name': 'Stefan Bleich, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'MHH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut für Arzneimittelsicherheit in der Psychiatrie AMSP e.V.', 'class': 'UNKNOWN'}, {'name': 'Asklepios Fachklinikum Brandenburg', 'class': 'UNKNOWN'}, {'name': 'Asklepios Fachklinikum Lübben für Psychiatrie, Psychotherapie und Psychosomatik', 'class': 'UNKNOWN'}, {'name': 'Asklepios Fachklinikum Teupitz für Psychiatrie', 'class': 'UNKNOWN'}, {'name': 'Krankenhaus Hedwigshöhe', 'class': 'UNKNOWN'}, {'name': 'Kompetenznetz TDM KJP e.V.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dr. Helge Frieling, Deputy Director of the Department of psychiatry, social psychiatry and psychotherapy', 'investigatorFullName': 'Helge Frieling,MD', 'investigatorAffiliation': 'Hannover Medical School'}}}}