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Trial record 2 of 3 for:    Dalmane OR FLURAZEPAM HYDROCHLORIDE OR DALMANE OR FLURAZEPAM OR RO 5-6901

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

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ClinicalTrials.gov Identifier: NCT00707915
Recruitment Status : Completed
First Posted : July 1, 2008
Results First Posted : March 26, 2012
Last Update Posted : March 27, 2012
Sponsor:
Information provided by (Responsible Party):
Minamihanno Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adverse Effects
Intervention Drug: Drug: Benzodiazepine (listed out below)
Enrollment 30
Recruitment Details psychiatric hospital & nursing home
Pre-assignment Details  
Arm/Group Title Dose-reduction
Hide Arm/Group Description The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Period Title: Overall Study
Started 30
Effects of Discontinuing Benzodiazepine 30
Completed 30
Not Completed 0
Arm/Group Title Dose-reduction
Hide Arm/Group Description The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
30
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
79.1  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
13
  43.3%
Male
17
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 30 participants
30
1.Primary Outcome
Title Completion Rate
Hide Description 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
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-reduction
Hide Arm/Group Description:
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: percentage of successful completers
26
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-reduction
Hide Arm/Group Description:
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.8  (3.2)
3.Secondary Outcome
Title Clinical Stabilometric Platform (CSP)
Hide Description 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.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-reduction
Hide Arm/Group Description:
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: cm
-1.5  (0.8)
4.Secondary Outcome
Title Critical Flicker Fusion Test (CFF)
Hide Description 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.
Time Frame Baseline and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-reduction
Hide Arm/Group Description:
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: Hz
2.1  (1.5)
5.Secondary Outcome
Title Leeds Sleep Evaluation Questionnaire (LSEQ)
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-reduction
Hide Arm/Group Description:
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
46.4  (32.9)
6.Secondary Outcome
Title Clinical Global Impression (CGI)
Hide Description 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.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dose-reduction
Hide Arm/Group Description:
The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.2  (1.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose-reduction
Hide Arm/Group Description The benzodiazepine dose will be discontinued in 4 weeks by a weekly 25% reduction. Participants will be observed for 8 weeks.
All-Cause Mortality
Dose-reduction
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dose-reduction
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose-reduction
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of clinical trials
Organization: Minami-hanno Hospital
Phone: 81.42.972.7111
Responsible Party: Minamihanno Hospital
ClinicalTrials.gov Identifier: NCT00707915     History of Changes
Other Study ID Numbers: MH0001
First Submitted: June 27, 2008
First Posted: July 1, 2008
Results First Submitted: July 20, 2011
Results First Posted: March 26, 2012
Last Update Posted: March 27, 2012