Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation

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

Tracking Information

• First Submitted Date: March 8, 2021
• First Posted Date: March 11, 2021
• Last Update Posted Date: March 11, 2021
• Estimated Study Start Date: March 10, 2021
• Estimated Primary Completion Date: June 20, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2021)

• 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 ]
• 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 ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation
• Official Title: Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation in Neuropsychiatric Disease

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Psychiatric Disorder
• Benzodiazepine-Related Disorders

Intervention

• 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

• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• O'brien CP. Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: March 8, 2021): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 20, 2023
• Estimated Primary Completion Date: June 20, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• intelligence score more than 80

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT04792658
• Other Study ID Numbers: long term of benzodiazepine
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Gellan Karamalllah Ramadan Ahmed, Assiut University
• Original Responsible Party: Same as current
• Current Study Sponsor: Assiut University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: March 2021