UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004187 |
|---|---|
| Receipt number | R000005015 |
| Scientific Title | Examination of the utility of Continuous Performance test in the diagnosis of the adulthood Attention Deficit / Hyperactivity Disorder |
| Date of disclosure of the study information | 2010/09/15 |
| Last modified on | 2010/09/10 13:52:26 |
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Basic information
Public title
Examination of the utility of Continuous Performance test in the diagnosis of the adulthood Attention Deficit / Hyperactivity Disorder
Acronym
Examination of the utility of CPT in adult AD/HD
Scientific Title
Examination of the utility of Continuous Performance test in the diagnosis of the adulthood Attention Deficit / Hyperactivity Disorder
Scientific Title:Acronym
Examination of the utility of CPT in adult AD/HD
Region
| Japan |
Condition
Condition
Attention Deficit / Hyperactivity Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among core symptom of adult AD/HD, I examine the laboratory procedure that can estimate impulsivity as carelessness objectively and am intended that I enable that I use CPT for assistance of not only the evaluation of treatment front and back but also the diagnosis.
Therefore I accumulate data of the normal control group and weigh it against data of the patient group.
In addition, I weigh it against the patient group having schizophrenia and pervasive developmental disorder,
It is the last aim to confirm that CPT is useful for an objective symptom evaluation of adult AD/HD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average Reaction time measured by CPT and coefficient of variation,Omission Error rate,Commision Error rate,
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
CPT was performed to 20 adulthood AD/HD patients.It was compared with the normal control group which matched age / sex with age / sex.
Different CPT of two kinds of conditions is performed,one enforcement is around one hour,it is carried out twice every around four weeks.
Interventions/Control_2
CPT was performed to 20 adulthood PDD patients.It was compared with the normal control group which matched age / sex with age / sex.
Different CPT of two kinds of conditions is performed,one enforcement is around one hour,it is carried out twice every around four weeks.
Interventions/Control_3
CPT was performed to 20 schizophrenia patients.It was compared with the normal control group which matched age / sex with age / sex.
Different CPT of two kinds of conditions is performed,one enforcement is around one hour,it is carried out twice every around four weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CAADID diagnostic criteria are used for the diagnosis of adult AD/HD
Diagnostic criteria of DSM-IV-TR are used for the diagnosis of the adult PDD.
Diagnostic criteria of DSM -IV-TR are used for the diagnosis of the schizophrenia.
(M.I.N.I) was performed for a person younger than 50 years 20 years old or older, and the person who fell under no diagnosis was chosen by normal control group.
Key exclusion criteria
A person having a chronic internal medicine disease, a pregnant woman, the retardation of mental development are excluded by a subject.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromichi Ishikawa |
Organization
Fukushima Medical University
Division name
Neuropsychiatry
Zip code
Address
1 Hikariga-oka, Fukushima City, Fukushima Prefecture
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukushima Medical University
Division name
Neuropsychiatry
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
| 2010 | Year | 09 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2010 | 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
| 2010 | Year | 09 | Month | 10 | Day |
Last modified on
| 2010 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005015
