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Sponsored by: |
Minamihanno Hospital |
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Information provided by: | Minamihanno Hospital |
ClinicalTrials.gov Identifier: | NCT00707915 |
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
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.
Condition | Intervention | Phase |
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Elderly |
Drug: benzodiazepine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effects of Discontinuation of Benzodiazepine-Derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study |
Estimated Enrollment: | 50 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
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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Drug: benzodiazepine
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. 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.
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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 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:
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenichi Tsunoda, MD | 81.42.972.7111 | tsunoken@mx3.ttcn.ne.jp |
Japan, Saitama | |
Minamihanno Hospital | Recruiting |
Hannou, Saitama, Japan, 357-0042 | |
Contact: Kenichi Tsunoda, MD 81.42.972.7111 tsunoken@mx3.ttcn.ne.jp | |
Minamihanno Hospital | Recruiting |
Hannou, Saitama, Japan, 357-0042 | |
Contact: Kenichi Tsunoda, MD 81.42.972.7111 |
Principal Investigator: | Kenichi Tsunoda, MD | Minamihanno Hospital |
Responsible Party: | Minamihanno Hospital ( Minamihanno Hospital ) |
Study ID Numbers: | MH0001 |
Study First Received: | June 27, 2008 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00707915 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
aged benzodiazepines hypnotics cognition posture |
Trazodone |