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

NCT00707915 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-27

Study results available
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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.

Conditions

  • Adverse Effects

Interventions

DRUG

Drug: Benzodiazepine (listed out below)

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.

Sponsors & Collaborators

  • Minamihanno Hospital

    lead OTHER

Principal Investigators

  • Kenichi Tsunoda, MD · Minamihanno Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Japan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00707915 on ClinicalTrials.gov