Psychiatric DisorderNCT04792658
Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation
An observational study of Psychiatric Disorder and Benzodiazepine-Related Disorders, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Benzodiazepine-Related Disorders
- What is being tested?
- Detailed interview with personal demographic data, Intelligence assessment using the Arabic version of the Wechsler Adult Intelligence Scale (WAIS) and The Arabic version of the Structured Interview for the Five-Factor Personality Model (SIFFM)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 2021to 20 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: participants who have use benzodiazepine more than 1 year and attend in outpatient clinic in Neuropsychiatric department will be included.
Who may be able to join
- age from 18 years to 50 years
- No history of neurological or medical illness
Who cannot join
- intelligence score more than 80
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Being tested
- Detailed interview with personal demographic data, Intelligence assessment using the Arabic version of the Wechsler Adult Intelligence Scale (WAIS), The Arabic version of the Structured Interview for the Five-Factor Personality Model (SIFFM), the Hamilton Depression Rating Scale, The Hamilton Anxiety Rating Scale
- Keywords
- psychiatric, benzodiazepine
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed interview with personal demographic dataBehavioural
, 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)Behavioural
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)Behavioural
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 ScaleBehavioural
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 ScaleBehavioural
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)Behavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the prevalence of DSM 5 psychiatric disorders associated with long term of benzodiazepine use
Measured: through study completion, an average of 1 year
measure of risk factor of DSM 5 psychiatric disorders associated with long term of benzodiazepine use
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start10 Mar 2021 (estimated)
- Primary completion20 Jun 2022 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792658
- Sponsor's protocol ID
- long term of benzodiazepine
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31274696O'brien CP. Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33.
PubMed 15762817Crowe 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.
PubMed 29244060
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Long Term of Benzodiazepine Use on Psychiatric Manifestation in Neuropsychiatric Disease
- ClinicalTrials.gov ID
- NCT04792658
- Acronym / sponsor ID
- long term of benzodiazepine
- Keywords
- psychiatric, benzodiazepine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Mar 2021 (estimated)
- Primary completion
- 20 Jun 2022 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- participants who have use benzodiazepine more than 1 year and attend in outpatient clinic in Neuropsychiatric department will be included.
Key inclusion criteria (2 listed)
- age from 18 years to 50 years
- No history of neurological or medical illness
Key exclusion criteria (1 listed)
- intelligence score more than 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detailed interview with personal demographic data, such as age, sex, education, history of occupation, past medical history, family history, medical, neurological, and psychiatric disorders. | Behavioural | – |
| 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 | Behavioural | – |
| 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 | Behavioural | – |
| the Hamilton Depression Rating Scaleit used for evaluation depression severity. It is 17 items and each item's score (0-4). with a total score range of 0-54 | Behavioural | – |
| The Hamilton Anxiety Rating Scaleit 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 | Behavioural | – |
| 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 | Behavioural | – |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Results publication: PubMed 31274696Shinfuku 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.
- Results publication: PubMed 15762817O'brien CP. Benzodiazepine use, abuse, and dependence. J Clin Psychiatry. 2005;66 Suppl 2:28-33.
- Results publication: PubMed 29244060Crowe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Benzodiazepine-Related Disorders, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gellan Ahmed (+201093663928, gillankaram@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792658, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.