UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004446 |
|---|---|
| Receipt number | R000005321 |
| Scientific Title | Efficacy and its determinant factors of donepezil monotherapy or combined therapy with low dose quetiapine or Yi-gan san for behavioral and psychological symptoms of dementia(BPSD): prospective observational study among hospitalized patients |
| Date of disclosure of the study information | 2010/11/11 |
| Last modified on | 2013/03/09 20:16:03 |
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Basic information
Public title
Efficacy and its determinant factors of donepezil monotherapy or combined therapy with low dose quetiapine or Yi-gan san for behavioral and psychological symptoms of dementia(BPSD): prospective observational study among hospitalized patients
Acronym
Efficacy of donepezil or conbined therapy with low dose quetiapin or Yi-gan san for BPSD.
Scientific Title
Efficacy and its determinant factors of donepezil monotherapy or combined therapy with low dose quetiapine or Yi-gan san for behavioral and psychological symptoms of dementia(BPSD): prospective observational study among hospitalized patients
Scientific Title:Acronym
Efficacy of donepezil or conbined therapy with low dose quetiapin or Yi-gan san for BPSD.
Region
| Japan |
Condition
Condition
BPSD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Application of use of atypical antipsychotics has been extended to large variety of mental disorder and recent studies report its efficacy for BPSD. However their use sometimes induces severe adverse effect or impairment of patient's quality of life.
It is known that some patients with BPSD can respond to donepezil monotherapy or combined therapy with low dose quetipine or Yi gan san. The study aims to clarify the efficacy and its determinant factors of this therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement in Clinical global impression scale
Key secondary outcomes
Factors affecting efficacy of the therapy
Incidence and severity of adverse effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients with BPSD
Patients can be followed or observed according to the study protocol
Patients or their caregivers can provide necessary information for the study
Key exclusion criteria
patient with severe or unstable physical disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoryoku Hino |
Organization
Ishikawa Prefectural Takamatsu Hospital
Division name
Department of Psychiatry
Zip code
Address
Ya-36,Uchi-Takamatsu, Kahoku City 929-1293,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Ishikawa Prefectural Takamatsu Hospital
Division name
Department of Psychiatry
Zip code
Address
TEL
Homepage URL
shoryok@ninus.ocn.ne.jp
Sponsor or person
Institute
Ishikawa Prefectural Takamatsu Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical characteristics are obtained from patients with BPSD at the first visit.According to our institutional protocol, patients undergo donepezil monotherapy, or combined therapy with low dose quetiapine or Yi gan san as needed. Effectiveness of the therapy and its determinant factors are evaluated.
Management information
Registered date
| 2010 | Year | 10 | Month | 26 | Day |
Last modified on
| 2013 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005321
