NCT04792658

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

March 11, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

March 8, 2021

Last Update Submit

March 8, 2021

Conditions

Keywords

psychiatricbenzodiazepine

Outcome Measures

Primary Outcomes (2)

  • measure the prevalence of DSM 5 psychiatric disorders associated with long term of benzodiazepine use

    through study completion, an average of 1 year

  • measure of risk factor of DSM 5 psychiatric disorders associated with long term of benzodiazepine use

    through study completion, an average of 1 year

Interventions

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

the test consists of six verbal subtests and five performance subtests. It used in measure Intelligence

it depend on a model of general language personality descriptors that based on theory suggests five broad dimensions to describe human personality

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

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

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

participants who have use benzodiazepine more than 1 year and attend in outpatient clinic in Neuropsychiatric department will be included.

You may qualify if:

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

You may not qualify if:

  • intelligence score more than 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Mental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer, resarcher OF Neurology and Psychiatry department

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

March 10, 2021

Primary Completion

June 20, 2022

Study Completion

September 20, 2023

Last Updated

March 11, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share