Clinical trial NCT00707915: Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons
Official title: Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adverse Effects
Keywords: aged
benzodiazepines
hypnotics
cognition
posture
Lead sponsor: Minamihanno Hospital
Sponsor class: OTHER
First posted: 2008-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Completion Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: A Change in a Total Scale Score in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version, From Baseline to Week 8.
timeFrame: Baseline and week 8
measure: Clinical Stabilometric Platform (CSP)
timeFrame: Baseline and week 8
measure: Critical Flicker Fusion Test (CFF)
timeFrame: Baseline and week 8
measure: Leeds Sleep Evaluation Questionnaire (LSEQ)
timeFrame: Week 8
measure: Clinical Global Impression (CGI)
timeFrame: Week 8
Other outcomes:
Locations:
city: Hannou
country: Japan
facility: Minamihanno Hospital
state: Saitama
Study officials:
affiliation: Minamihanno Hospital
name: Kenichi Tsunoda, MD
role: PRINCIPAL_INVESTIGATOR
References: