Adverse Effects Clinical Trial
Official title:
Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study
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
1. Primary Objective The primary objective is to examine the feasibility of discontinuing
BZD-derivative hypnotics in older people.
2. Secondary Objectives
1. One of the secondary objectives is to examine the magnitude of discontinuing
BZD-derivative hypnotics in the stability of body.
2. Another secondary objective is to examine the magnitude of discontinuing
BZD-derivative hypnotics in cognitive function.
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:
1. Clinical worsening in sleep defined as a CGI-Global Improvement score of 7
2. Participant's request
3. Clinical decision on the part of the physician of record or independent consulting
physician In the event that a participant needs a dose increment for anxiety and
insomnia, the dose will be increased back to the previous dose, and they will be
followed for the rest of the study period. In addition, the use of trazodone (25-100
mg/day) will be allowed anytime throughout the study period.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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