drugset / Trial / NCT00707915

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

NCT00707915

Phase 4 Completed 30 enrolled Minamihanno Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2008-01
Primary completion
2010-07
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Brotizolam Small molecule
Subject Diazepam Small molecule
Subject Estazolam Small molecule
Subject Flurazepam Small molecule
Subject etizolam Small molecule
Subject flunitrazepam Small molecule
Subject nitrazepam Small molecule
Subject quazepam Small molecule

Indications

No indication recorded.