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Effects of Discontinuation of Benzodiazepine-Derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons
This study is currently recruiting participants.
Verified by Minamihanno Hospital, June 2008
Sponsored by: Minamihanno Hospital
Information provided by: Minamihanno Hospital
ClinicalTrials.gov Identifier: NCT00707915
  Purpose

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.


Condition Intervention Phase
Elderly
Drug: benzodiazepine
Phase IV

Drug Information available for: Trazodone Trazodone hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Effects of Discontinuation of Benzodiazepine-Derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons: a Pilot Study

Further study details as provided by Minamihanno Hospital:

Primary Outcome Measures:
  • Completion rate [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Japanese Version [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Clinical Stabilometric Platform (CSP) [ Time Frame: 8 week ] [ Designated as safety issue: No ]
  • Critical Flicker Fusion Test (CFF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Leeds Sleep Evaluation Questionnaire (LSEQ) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions [ Time Frame: 2, 4, 6, and 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Drug: benzodiazepine
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. 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.

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707915

Contacts
Contact: Kenichi Tsunoda, MD 81.42.972.7111 tsunoken@mx3.ttcn.ne.jp

Locations
Japan, Saitama
Minamihanno Hospital Recruiting
Hannou, Saitama, Japan, 357-0042
Contact: Kenichi Tsunoda, MD     81.42.972.7111     tsunoken@mx3.ttcn.ne.jp    
Minamihanno Hospital Recruiting
Hannou, Saitama, Japan, 357-0042
Contact: Kenichi Tsunoda, MD     81.42.972.7111        
Sponsors and Collaborators
Minamihanno Hospital
Investigators
Principal Investigator: Kenichi Tsunoda, MD Minamihanno Hospital
  More Information

Responsible Party: Minamihanno Hospital ( Minamihanno Hospital )
Study ID Numbers: MH0001
Study First Received: June 27, 2008
Last Updated: June 30, 2008
ClinicalTrials.gov Identifier: NCT00707915  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Minamihanno Hospital:
aged
benzodiazepines
hypnotics
cognition
posture

Study placed in the following topic categories:
Trazodone

ClinicalTrials.gov processed this record on January 16, 2009