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

NCT00707915 | Completed Phase 4 Results

• 1 other identifier: MH0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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. 1.Primary Objective The primary objective is to examine the feasibility of discontinuing BZD-derivative hypnotics in older people.
2. 2.Secondary Objectives
3. 3.One of the secondary objectives is to examine the magnitude of discontinuing BZD-derivative hypnotics in the stability of body.
4. 4.Another secondary objective is to examine the magnitude of discontinuing BZD-derivative hypnotics in cognitive function.

Conditions

Adverse Effects

Keywords

aged; benzodiazepines; hypnotics; cognition; posture

Outcome Measures

Primary Outcomes (1)

• Completion Rate

  The number of subjects who have successfully completed dose-reduction and all the assessments scheduled until week 8 divided by the total number of enrolled subjects

  8 weeks

Secondary Outcomes (5)

• 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.

  Baseline and week 8

• Clinical Stabilometric Platform (CSP)

  Baseline and week 8

• Critical Flicker Fusion Test (CFF)

  Baseline and week 8

• Leeds Sleep Evaluation Questionnaire (LSEQ)

  Week 8

• Clinical Global Impression (CGI)

  Week 8

Study Arms (1)

Dose reduction

EXPERIMENTAL

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

Drug: Drug: Benzodiazepine (listed out below)

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.

Dose reduction

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minamihanno Hospital: lead

Study Sites (1)

Minamihanno Hospital

Hannou, Saitama, 357-0042, Japan

Location

MeSH Terms

Interventions

Benzodiazepines

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of clinical trials
• Organization: Minami-hanno Hospital

haloperidol1mg@hotmail.com

81.42.972.7111

Study Officials

• Kenichi Tsunoda, MD

  Minamihanno Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 27, 2012
• Results First Posted: March 26, 2012

Record last verified: 2012-03

Locations

JP (1)