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

NCT ID: NCT00707915

Last Updated: 2012-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-07-31

Brief 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.

Detailed Description

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 study, we examined changes in motor and cognitive functions following the discontinuation of BZD hypnotics in older persons.

In this 8-week open-label study, subjects aged 50 or older who receive BZD as a hypnotic and do not have any unstable physical illness, or neurological disorder will be recruited. The BZD dose will be discontinued in 4 weeks by a weekly 25% reduction.

Following assessments will be performed at baseline 12 hours postdose and at endpoint: the Clinical Stabilometric Platform (CSP), the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and the Critical Flicker Fusion Test (CFF), the Leeds Sleep Evaluation Questionnaire (LSEQ). The CSP measures the stability of body, with the eyes opened or closed.

All psychotropic agents other than the BZD-derivative hypnotics will be kept constant throughout the study.

The dose reduction will be terminated if any of the following conditions are fulfilled:

1. Clinical worsening in sleep defined as a CGI-Global Improvement score of 7

2. Participant's request

3. Clinical decision on the part of the physician of record or independent consulting physician In the event that a participant needs a dose increment for anxiety and insomnia, the dose will be increased back to the previous dose, and they will be followed for the rest of the study period. In addition, the use of trazodone (25-100 mg/day) will be allowed anytime throughout the study period.

Conditions

Adverse Effects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose reduction

The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.

Group Type: EXPERIMENTAL

Drug: Benzodiazepine (listed out below)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minamihanno Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenichi Tsunoda, MD

Role: PRINCIPAL_INVESTIGATOR

Minamihanno Hospital

Locations

Minamihanno Hospital

Hannou, Saitama, Japan

Countries

Japan

Other Identifiers

MH0001

Identifier Type: -

Identifier Source: org_study_id