Trial Outcomes & Findings for Effects of Discontinuation of Benzodiazepine-derivative Hypnotics on Cognitive and Motor Functions in Elderly Persons (NCT NCT00707915)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

8 weeks

Results posted on

2012-03-27

Participant Flow

psychiatric hospital \& nursing home

Participant milestones

Participant milestones
Measure	Dose-reduction The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Study STARTED	30
Overall Study Effects of Discontinuing Benzodiazepine	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose-reduction n=30 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants
Age Continuous	79.1 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Japan	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Outcome measures
Measure	Dose-reduction n=30 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Completion Rate	26 percentage of successful completers

SECONDARY outcome

Timeframe: Baseline and week 8

This brief test is to assess areas of cognitive functioning and profile impairment across domains with 12 subtests, including: List Learning, Story Memory, Figure Copy, Line Orientation, Digit Span, Coding, Picture Naming, Semantic Fluency, List Recall, List Recognition, Story Recall, and Figure Recall. This assessment is repeatable and not subject to practice effects. A total scale score ranges between 40 and 160; a higher score indicates better cognitive function. A change in the score between the baseline and week 8 is defined as a secondary outcome measure.

Outcome measures

Outcome measures
Measure	Dose-reduction n=26 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
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.	8.8 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline and week 8

CSP (ANIMA® GS-7, Tokyo) measures a total length of the trunk motion by varying the resistance applied to the platform for 30 seconds with eyes closed with feet together. Change in the total length of the trunk motion from baseline to week 8 will be recorded.

Outcome measures

Outcome measures
Measure	Dose-reduction n=26 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Clinical Stabilometric Platform (CSP)	-1.5 cm Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline and week 8

The CFF threshold has been regarded as a functional measure of psychomotor function. Sub-threshold intermittent light is perceived as a flicker. If the frequency is gradually increased, the flicker becomes gradually less distinct until it is finally perceived as a continuous light (fusion threshold). The device (T.K.K.501c) provides luminance with a mean intensity of 500Lux±10% and a range of frequency of 20-60Hz. A change in the critical fusion frequency from baseline to week 8 will be recorded.

Outcome measures

Outcome measures
Measure	Dose-reduction n=26 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Critical Flicker Fusion Test (CFF)	2.1 Hz Standard Deviation 1.5

SECONDARY outcome

Timeframe: Week 8

The LSEQ comprises 10 self-rating 100-mm-line analogue questions regarding changes in the quality of sleep and early morning behavior, following any given intervention. Scores range between 0 and 100. Scores beneath 50 indicate better sleep. This will be performed at week 8.

Outcome measures

Outcome measures
Measure	Dose-reduction n=26 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Leeds Sleep Evaluation Questionnaire (LSEQ)	46.4 units on a scale Standard Deviation 32.9

SECONDARY outcome

Timeframe: Week 8

The CGI rating scales are commonly used measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders (Guy, W., 1976). The CGI - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. This will be performed at week 8.

Outcome measures

Outcome measures
Measure	Dose-reduction n=30 Participants The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Clinical Global Impression (CGI)	4.2 units on a scale Standard Deviation 1.8

Adverse Events

Dose-reduction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of clinical trials

Minami-hanno Hospital

Phone: 81.42.972.7111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place