Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation

NCT ID: NCT04792658

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2023-09-20

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.

Conditions

Psychiatric Disorder; Benzodiazepine-Related Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Detailed interview with personal demographic data

, such as age, sex, education, history of occupation, past medical history, family history, medical, neurological, and psychiatric disorders.

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Gellan Karamalllah Ramadan Ahmed

lecturer, resarcher OF Neurology and Psychiatry department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

gellan Ahmed

Role: CONTACT

gillankaram@aun.edu.eg

+201093663928

References

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.

Reference Type: RESULT

PMID: 31274696 (View on PubMed)

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

Reference Type: RESULT

PMID: 15762817 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29244060 (View on PubMed)

Other Identifiers

long term of benzodiazepine

Identifier Type: -

Identifier Source: org_study_id