Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation

Psychiatric Disorder Clinical Trial

Official title:

Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation in Neuropsychiatric Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04792658
• Other study ID #: long term of benzodiazepine
• Status: Not yet recruiting
• Start date: March 10, 2021
• Est. completion date: September 20, 2023

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: gellan Ahmed
• Phone: +201093663928
• Email: gillankaram[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 20, 2023
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• age from 18 years to 50 years

• No history of neurological or medical illness

Exclusion Criteria:

• intelligence score more than 80

Related Conditions & MeSH terms

• Benzodiazepine-Related Disorders
• Disease
• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

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.
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. Review. — View Citation

O'brien CP. Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33. Review. — View 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.0000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure the prevalence of DSM 5 psychiatric disorders associated with long term of benzodiazepine use		through study completion, an average of 1 year
Primary	measure of risk factor of DSM 5 psychiatric disorders associated with long term of benzodiazepine use		through study completion, an average of 1 year