Clinical trial NCT04792658: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psychiatric Disorder
Benzodiazepine-Related Disorders
Keywords: psychiatric
benzodiazepine
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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

Primary outcomes:
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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: O'brien CP. Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33.
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.