Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2025-12-28 @ 9:15 PM
Study NCT ID:
NCT04792658
Status:
UNKNOWN
Last Update Posted:
2021-03-11
First Post:
2021-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2023-09-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure the prevalence of DSM 5 psychiatric disorders associated with long term of benzodiazepine use', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'measure of risk factor of DSM 5 psychiatric disorders associated with long term of benzodiazepine use', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychiatric', 'benzodiazepine'], 'conditions': ['Psychiatric Disorder', 'Benzodiazepine-Related Disorders']}, 'referencesModule': {'references': [{'pmid': '31274696', 'type': 'RESULT', 'citation': 'Shinfuku M, Kishimoto T, Uchida H, Suzuki T, Mimura M, Kikuchi T. Effectiveness and safety of long-term benzodiazepine use in anxiety disorders: a systematic review and meta-analysis. Int Clin Psychopharmacol. 2019 Sep;34(5):211-221. doi: 10.1097/YIC.0000000000000276.'}, {'pmid': '15762817', 'type': 'RESULT', 'citation': "O'brien CP. Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33."}, {'pmid': '29244060', 'type': 'RESULT', 'citation': 'Crowe SF, Stranks EK. The Residual Medium and Long-term Cognitive Effects of Benzodiazepine Use: An Updated Meta-analysis. Arch Clin Neuropsychol. 2018 Nov 1;33(7):901-911. doi: 10.1093/arclin/acx120.'}]}, 'descriptionModule': {'briefSummary': 'Benzodiazepines are usually a secondary drug of abuse-used mainly to augment the high received from another drug or to offset the adverse effects of other drugs. Few cases of addiction arise from legitimate use of benzodiazepines. Pharmacologic dependence, a predictable and natural adaptation of a body system long accustomed to the presence of a drug, may occur in patients taking therapeutic doses of benzodiazepines. However, this dependence, which generally manifests itself in withdrawal symptoms upon the abrupt discontinuation of the medication, may be controlled and ended through dose tapering, medication switching, and/or medication augmentation. Due to the chronic nature of anxiety, long-term low-dose benzodiazepine treatment may be necessary for some patients; this continuation of treatment should not be considered abuse or addiction.\n\nprevious study reported that The results of the study are important in that they corroborate the mounting evidence that a range of neuropsychological functions are impaired as a result of long-term benzodiazepine use, and that these are likely to persist even following withdrawal. The findings highlight the residual neurocognitive compromise associated with long-term benzodiazepine therapy as well as the important clinical implications of these results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'participants who have use benzodiazepine more than 1 year and attend in outpatient clinic in Neuropsychiatric department will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 18 years to 50 years\n* No history of neurological or medical illness\n\nExclusion Criteria:\n\n* intelligence score more than 80'}, 'identificationModule': {'nctId': 'NCT04792658', 'briefTitle': 'Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation in Neuropsychiatric Disease', 'orgStudyIdInfo': {'id': 'long term of benzodiazepine'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Detailed interview with personal demographic data', 'type': 'BEHAVIORAL', 'description': ', such as age, sex, education, history of occupation, past medical history, family history, medical, neurological, and psychiatric disorders.'}, {'name': 'Intelligence assessment using the Arabic version of the Wechsler Adult Intelligence Scale (WAIS)', 'type': 'BEHAVIORAL', 'description': 'the test consists of six verbal subtests and five performance subtests. It used in measure Intelligence'}, {'name': 'The Arabic version of the Structured Interview for the Five-Factor Personality Model (SIFFM)', 'type': 'BEHAVIORAL', 'description': 'it depend on a model of general language personality descriptors that based on theory suggests five broad dimensions to describe human personality'}, {'name': 'the Hamilton Depression Rating Scale', 'type': 'BEHAVIORAL', 'description': "it used for evaluation depression severity. It is 17 items and each item's score (0-4). with a total score range of 0-54"}, {'name': 'The Hamilton Anxiety Rating Scale', 'type': 'BEHAVIORAL', 'description': 'it used for evaluation the severity of anxiety. The scale consists of 14 items and each item is scored on a scale from 0 to 4 , with a total score range of 0-56'}, {'name': 'The Minnesota Multiphasic Personality Inventory-2 (MMPI-2)', 'type': 'BEHAVIORAL', 'description': 'It used to evaluate range of symptoms of psychopathology and personality traits that are maladaptive. It has 10 clinical scales subscales included the following: 1, hypochondriasis (Hs); 2, depression (D); 3, hysteria (Hy); 4, psychopathic deviation (Pd); 5, masculinity-femininity (Mf); 6, paranoia (Pa); 7, psychophrenia (Pt); 8, schizophrenia (Sc); 9, hypomania (Ma); 10, social introversion (Ma); (Si). More than 65 responses were considered symptomatic'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'gellan Ahmed', 'role': 'CONTACT', 'email': 'gillankaram@aun.edu.eg', 'phone': '+201093663928'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer, resarcher OF Neurology and Psychiatry department', 'investigatorFullName': 'Gellan Karamalllah Ramadan Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}