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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004187
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Fukushima Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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