UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006558 |
|---|---|
| Receipt number | R000007768 |
| Scientific Title | A research of efficacy and safety of aripiprazole treatment for the behavioral symptoms in subjects with pervasive developmental disordes. |
| Date of disclosure of the study information | 2011/10/20 |
| Last modified on | 2014/08/25 09:40:29 |
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Basic information
Public title
A research of efficacy and safety of aripiprazole treatment for the behavioral symptoms in subjects with pervasive developmental disordes.
Acronym
A reseach of aripiprazole treatment for the behavioral symptoms in subjects with pervasive developmental disordes.
Scientific Title
A research of efficacy and safety of aripiprazole treatment for the behavioral symptoms in subjects with pervasive developmental disordes.
Scientific Title:Acronym
A reseach of aripiprazole treatment for the behavioral symptoms in subjects with pervasive developmental disordes.
Region
| Japan |
Condition
Condition
Pervasive Developmental Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and tolerability of aripiprazole for the behavioral symptoms in children and adolescents with PDD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aberrant Behavior Checklist irritability
Key secondary outcomes
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
continuous administration of aripiprazole
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
| 6 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with pervasive developmental disorders(PDD) based on the classifications in the
diagnostic and statistical manual of
mental disorders (DSM-IV)
Key exclusion criteria
1. Children less than 6 years old.
2. Participants were excluded if they had
a history of major medical or
neurological illness including epilepsy,
significant head trauma, or a lifetime
history of alcohol or drug dependence.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ishitobi Makoto |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
Address
Matsuokashimoaizuki, Eiheiji, Fukui,
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Neuropsychiatry
Zip code
Address
TEL
0776-61-3111
Homepage URL
Sponsor or person
Institute
Department of Neuropsychiatry, Faculty
of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, Faculty
of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
Management information
Registered date
| 2011 | Year | 10 | Month | 17 | Day |
Last modified on
| 2014 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007768
