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Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as cognitive functions, which in turn could result in lethal incidents including falls especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail population. In this 8-week open-label study, we examined changes in motor and cognitive functions following the discontinuation of BZD hypnotics in older persons.
OBJECTIVES & HYPOTHESES
Primary Objective The primary objective is to examine the feasibility of discontinuing BZD-derivative hypnotics in older people.
Secondary Objectives
Hypotheses
1. More than 80% of the participants will complete and tolerate all the study procedures.
2a. Participants will show an improvement in the stability of body. 2b. Participants will show an improvement in the cognitive function globally as well as specifically in attention.
Benzodiazepines (BZDs) have been reported to cause negative impacts on motor as well as cognitive functions, which in turn could result in lethal incidents including falls especially in the elderly. This notwithstanding, few trials have evaluated a feasibility and benefits of discontinuing BZD-derivative hypnotics in a systematic manner in this frail population. In this study, we examined changes in motor and cognitive functions following the discontinuation of BZD hypnotics in older persons.
In this 8-week open-label study, subjects aged 50 or older who receive BZD as a hypnotic and do not have any unstable physical illness, or neurological disorder will be recruited. The BZD dose will be discontinued in 4 weeks by a weekly 25% reduction.
Following assessments will be performed at baseline 12 hours postdose and at endpoint: the Clinical Stabilometric Platform (CSP), the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Critical Flicker Fusion Test (CFF), the Leeds Sleep Evaluation Questionnaire (LSEQ). The CSP measures the stability of body, with the eyes opened or closed.
All psychotropic agents other than the BZD-derivative hypnotics will be kept constant throughout the study.
The dose reduction will be terminated if any of the following conditions are fulfilled:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose reduction | Experimental | The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Benzodiazepine (listed out below) | Drug | The benzodiazepine (BZD) dose will be discontinued in 4 weeks by a weekly 25% reduction. BZD-derivative hypnotics will include brotizolam, flunitrazepam, etizolam, quazepam, estazolam, nitrazepam, flurazepam, and diazepam. All psychotropic agents other than the BZD-derivative hypnotics will be kept constant throughout the study. In addition, the use of trazodone (25-100 mg/day) will be allowed anytime throughout the study period. Subjects will be observed for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate | The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8. | This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenichi Tsunoda, MD | Minamihanno Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minamihanno Hospital | Hannou | Saitama | 357-0042 | Japan |
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psychiatric hospital & nursing home
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose-reduction | The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose-reduction | The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion Rate | The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects | Posted | Number | percentage of successful completers | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose-reduction | The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of clinical trials | Minami-hanno Hospital | 81.42.972.7111 | haloperidol1mg@hotmail.com |
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| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Baseline and week 8 |
| Clinical Stabilometric Platform (CSP) | CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded. | Baseline and week 8 |
| Critical Flicker Fusion Test (CFF) | The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded. | Baseline and week 8 |
| Leeds Sleep Evaluation Questionnaire (LSEQ) | The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8. | Week 8 |
| Clinical Global Impression (CGI) | The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8. | Week 8 |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8. | This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline and week 8 |
|
|
|
| Secondary | Clinical Stabilometric Platform (CSP) | CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded. | Posted | Mean | Standard Deviation | cm | Baseline and week 8 |
|
|
|
| Secondary | Critical Flicker Fusion Test (CFF) | The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded. | Posted | Mean | Standard Deviation | Hz | Baseline and week 8 |
|
|
|
| Secondary | Leeds Sleep Evaluation Questionnaire (LSEQ) | The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
|
|
|
| Secondary | Clinical Global Impression (CGI) | The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8. | Posted | Mean | Standard Deviation | units on a scale | Week 8 |
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| 30 |
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| 30 |
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