Overview

Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons

Status:
Completed
Trial end date:
2010-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Minamihanno Hospital
Treatments:
Hypnotics and Sedatives
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.