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Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation

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ClinicalTrials.gov Identifier: NCT04792658
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Gellan Karamalllah Ramadan Ahmed, Assiut University

Study Description
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Brief Summary:

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.

previous 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.


Condition or disease Intervention/treatment
Psychiatric Disorder Benzodiazepine-Related Disorders Behavioral: Detailed interview with personal demographic data Behavioral: Intelligence assessment using the Arabic version of the Wechsler Adult Intelligence Scale (WAIS) Behavioral: The Arabic version of the Structured Interview for the Five-Factor Personality Model (SIFFM) Behavioral: the Hamilton Depression Rating Scale Behavioral: The Hamilton Anxiety Rating Scale Behavioral: The Minnesota Multiphasic Personality Inventory-2 (MMPI-2)

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation in Neuropsychiatric Disease
Estimated Study Start Date : March 10, 2021
Estimated Primary Completion Date : June 20, 2022
Estimated Study Completion Date : September 20, 2023
Groups and Cohorts
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Intervention Details:
  • Behavioral: Detailed interview with personal demographic data
    , such as age, sex, education, history of occupation, past medical history, family history, medical, neurological, and psychiatric disorders.
  • Behavioral: Intelligence assessment using the Arabic version of the Wechsler Adult Intelligence Scale (WAIS)
    the test consists of six verbal subtests and five performance subtests. It used in measure Intelligence
  • Behavioral: The Arabic version of the Structured Interview for the Five-Factor Personality Model (SIFFM)
    it depend on a model of general language personality descriptors that based on theory suggests five broad dimensions to describe human personality
  • Behavioral: the Hamilton Depression Rating Scale
    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
  • Behavioral: The Hamilton Anxiety Rating Scale
    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
  • Behavioral: The Minnesota Multiphasic Personality Inventory-2 (MMPI-2)
    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

Outcome Measures
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Primary Outcome Measures :
  1. measure the prevalence of DSM 5 psychiatric disorders associated with long term of benzodiazepine use [ Time Frame: through study completion, an average of 1 year ]
  2. measure of risk factor of DSM 5 psychiatric disorders associated with long term of benzodiazepine use [ Time Frame: through study completion, an average of 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
participants who have use benzodiazepine more than 1 year and attend in outpatient clinic in Neuropsychiatric department will be included.
Criteria

Inclusion Criteria:

  • age from 18 years to 50 years
  • No history of neurological or medical illness

Exclusion Criteria:

  • intelligence score more than 80
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04792658


Contacts
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Contact: gellan Ahmed +201093663928 gillankaram@aun.edu.eg

Sponsors and Collaborators
Assiut University
More Information
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Publications of Results:

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Responsible Party: Gellan Karamalllah Ramadan Ahmed, lecturer, resarcher OF Neurology and Psychiatry department, Assiut University
ClinicalTrials.gov Identifier: NCT04792658    
Other Study ID Numbers: long term of benzodiazepine
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gellan Karamalllah Ramadan Ahmed, Assiut University:
psychiatric
benzodiazepine
Additional relevant MeSH terms:
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Disease
Mental Disorders
Problem Behavior
Pathologic Processes
Behavioral Symptoms