Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT04484558
Status:
UNKNOWN
Last Update Posted:
2020-07-23
First Post:
2020-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-22', 'studyFirstSubmitDate': '2020-02-16', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection and measureing anxiety and depressive symptoms in ischemic stroke patients treated with rtpA .', 'timeFrame': '15 minutes', 'description': 'Hamilton depression and anxiety rating scale'}], 'secondaryOutcomes': [{'measure': 'Measuring quality of life in patients with ischemic stroke treated wih rtpA .', 'timeFrame': '10 minutes', 'description': 'Quality of life questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Stroke', 'Anxiety Disorders', 'Depression']}, 'referencesModule': {'references': [{'pmid': '19675247', 'type': 'BACKGROUND', 'citation': 'Musumeci G, Sciarretta C, Rodriguez-Moreno A, Al Banchaabouchi M, Negrete-Diaz V, Costanzi M, Berno V, Egorov AV, von Bohlen Und Halbach O, Cestari V, Delgado-Garcia JM, Minichiello L. TrkB modulates fear learning and amygdalar synaptic plasticity by specific docking sites. J Neurosci. 2009 Aug 12;29(32):10131-43. doi: 10.1523/JNEUROSCI.1707-09.2009.'}, {'pmid': '21346243', 'type': 'BACKGROUND', 'citation': 'Noble EE, Billington CJ, Kotz CM, Wang C. The lighter side of BDNF. Am J Physiol Regul Integr Comp Physiol. 2011 May;300(5):R1053-69. doi: 10.1152/ajpregu.00776.2010. Epub 2011 Feb 23.'}, {'pmid': '17543031', 'type': 'BACKGROUND', 'citation': "Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x."}, {'pmid': '18701066', 'type': 'RESULT', 'citation': 'Li Y, Luikart BW, Birnbaum S, Chen J, Kwon CH, Kernie SG, Bassel-Duby R, Parada LF. TrkB regulates hippocampal neurogenesis and governs sensitivity to antidepressive treatment. Neuron. 2008 Aug 14;59(3):399-412. doi: 10.1016/j.neuron.2008.06.023.'}]}, 'descriptionModule': {'briefSummary': 'In fact theWorld Health Organization estimates that 2-3% in general populations of countries across the world tend to be affected by severe mental disorders (1) Thrombolytic therapy seems to be of great importance in achieving better quality of life in ischemic stroke patients who respond to this therapy(rTPA).', 'detailedDescription': 'There is a substantial body of evidenc suggesting a strong relation between neurotrophic factors and depression and anxiety pathogenesis (2,8) Brain-derived neurotrophic factor (BDNF), a member of the neurotrophic family known to regulate neuronal plasticity and survival , may play an important role in the pathophysiology of depression and anxiety (3,9).\n\nDifferent studies indicated patients who were exposed to traumatic events have anxiety comorbidity and lower levels of serum BDNF compared to those without a history of traumatic events (4) .\n\nBDNF has an antidepressant and anxiolytic effect which suggest that BDNF is implicated in the regulation of anxiety-related behaviors. which leads to a valine-to-methionine change in the proBDNF protein, was associated with lower activity-dependent secretion of BDNF (5)and has been implicated with increased susceptibility to neuropsychiatric disorders including depression, anxiety-related dysfunction, and bipolar disorder , all these studies suggest that BDNF is likely to be an important etiological factor in memory, depression and anxiety disorders (6,10).\n\nBDNF arises from a precursor, proBDNF, which is cleaved to produce the mature protein through the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can regulate the action of BDNFarises from a precursor, proBDNF, which is cleaved to produce the mature protein through the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can regulate the action of BDNF (7).\n\nThe purpose of this study is to examine the quality of life after stroke of patients treated with thrombolysis .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Data will be collected from the clinical interpretation of the patients at presentation and from the recent patients' medical records which have the full medical histories and examinations. All patients will be subjected to full neurological history and examination. The results of the above mentioned laboratory, investigations will be included in future analysis and interpretation of patients' abnormal neurological findings.", 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age more than 40.\n2. None of the pt had history of other psychiatric illness.\n3. male and female.\n\nExclusion Criteria:\n\n* 1-smoker. 2-substance abuser or dependence. 3-History of other psychiatric illness. 4-History of other neurological illness.'}, 'identificationModule': {'nctId': 'NCT04484558', 'briefTitle': 'Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke', 'orgStudyIdInfo': {'id': '01001297992'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Actilyse', 'type': 'DRUG', 'otherNames': ['rTpA'], 'description': 'Infusion'}]}, 'contactsLocationsModule': {'locations': [{'zip': '17111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ebtsam MM Tawfik, M.D.', 'role': 'CONTACT', 'email': 'Ebtsamtawfik393@gmail.com', 'phone': '01001297992'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ebtsam Mohamed Tawfik', 'role': 'CONTACT', 'email': 'ebtsamtawfik393@gmail.com', 'phone': '+0201001297992'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Ebtsam Tawfik', 'investigatorAffiliation': 'Assiut University'}}}}