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


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 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


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

Value
https://center6.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