- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792658
Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation
Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation in Neuropsychiatric Disease
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.
Study Overview
Status
Intervention / Treatment
- 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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age from 18 years to 50 years
- No history of neurological or medical illness
Exclusion Criteria:
- intelligence score more than 80
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- long term of benzodiazepine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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