Phase 4
N=30
Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons
Adverse Effects
Bottom Line
View on ClinicalTrials.gov: NCT00707915 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Completion Rate — 26 percentage of successful completers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Drug: Benzodiazepine (listed out below) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Minamihanno Hospital
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rate |
26 | — |
| 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. |
8.8 | — |
| SECONDARY Clinical Stabilometric Platform (CSP) |
-1.5 | — |
| SECONDARY Critical Flicker Fusion Test (CFF) |
2.1 | — |
| SECONDARY Leeds Sleep Evaluation Questionnaire (LSEQ) |
46.4 | — |
| SECONDARY Clinical Global Impression (CGI) |
4.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Male or female participants of any race or ethnicity with any psychiatric diagnosis
- Age of 50 and older
- Having been treated with an BZD-derivative hypnotic drug at a steady dose for at least 4 weeks
Exclusion Criteria
- Incapacity to follow the instructions.
- Unstable physical illness or significant neurological disorder
- Psychiatric concerns raised by the physician of record regarding participation in the study.
Data sourced from ClinicalTrials.gov (NCT00707915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.