UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007711 |
|---|---|
| Receipt number | R000008450 |
| Scientific Title | Effect of aripiperazole on psychiatric symptoms in patients with Parkinson disease |
| Date of disclosure of the study information | 2012/04/12 |
| Last modified on | 2013/07/20 08:06:46 |
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Basic information
Public title
Effect of aripiperazole on psychiatric symptoms in patients with Parkinson disease
Acronym
Effect of aripiperazole on PD psychosis
Scientific Title
Effect of aripiperazole on psychiatric symptoms in patients with Parkinson disease
Scientific Title:Acronym
Effect of aripiperazole on PD psychosis
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Study the effectiveness of aripipurazole on psychosis of patients with Parkinsons disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
BPRS, adverse effect
Key secondary outcomes
UPDRS, CI-I, CGI-S,MMSE,FAB
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aripipurazole treatment
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with idiopathic Parkinson disease with hallucination, delusion or both.
Key exclusion criteria
Patients accompanied by serious physical condition or disturbed central nervous system functioning which can cause psychosis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Kashihara |
Organization
Okayama Kyokuto Hospital
Division name
Department of Neurology
Zip code
Address
567-1 Kurata, Naka-ku, Okayama 703-8265, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama Kyokuto Hospital
Division name
Department of Neurology
Zip code
Address
TEL
Homepage URL
kkashi@kyokuto.or.jp
Sponsor or person
Institute
Parkinson Study Group Japan
Institute
Department
Personal name
Funding Source
Organization
Research Committee of CNS Degenerative Diseases, the Ministry of Health, Labour and Welfare of Japan.
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 04 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 10 | Day |
Last modified on
| 2013 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008450
