CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Drug: Benzodiazepine (listed out below)drug
Likely dose
Drug: Benzodiazepine (listed out below) 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00707915
NCT00707915Phase 4Completed
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Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study

Minamihanno Hospital·interventional·Posted Jul 1, 2008·Updated Mar 27, 2012

In Brief

A Phase 4 clinical trial evaluating Drug: Benzodiazepine (listed out below) for Adverse Effects. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdverse Effects
CountriesJapan
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 1, 2008
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.0 years ago

Interventions

Drug: Benzodiazepine (listed out below)drug

The benzodiazepine (BZD) dose will be discontinued in 4 weeks by a weekly 25% reduction. BZD-derivative hypnotics will include brotizolam, flunitrazepam, etizolam, quazepam, estazolam, nitrazepam, flurazepam, and diazepam. 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.