UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042121
Receipt number R000048072
Scientific Title Study of reliability and validity of DIVA-5(a new semi-structured interview based on DSM-5) in patients with adult ADHD
Date of disclosure of the study information 2020/10/15
Last modified on 2020/10/23 17:25:19

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Basic information

Public title

Study of reliability and validity of DIVA-5(a new semi-structured interview based on DSM-5) in patients with adult ADHD

Acronym

Study of reliability and validity of DIVA-5(a new semi-structured interview based on DSM-5) in patients with adult ADHD

Scientific Title

Study of reliability and validity of DIVA-5(a new semi-structured interview based on DSM-5) in patients with adult ADHD

Scientific Title:Acronym

Study of reliability and validity of DIVA-5(a new semi-structured interview based on DSM-5) in patients with adult ADHD

Region

Japan


Condition

Condition

Attention Deficit and Hyperactivity Disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the reliability and validity of the Japanese version of DIVA-5 (a new semi-structured interview based on DSM-5)

Basic objectives2

Others

Basic objectives -Others

To evaluate the correlation between DIVA-5 and neurocognitive function.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To examine the significant correlation between DIVA-5 and Conners' Adult ADHD Rating Scale. To examine the significant correlation of DIVA-5 among two raters.

Key secondary outcomes

To examine the significant correlation between DIVA-5 and neuropsychological tests.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Behavior,custom

Interventions/Control_1

to evaluate symptoms using a rating scale in a clinical interview.

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

18 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

1.adults between 18 and 60 years of age who are aware of either inattention, hyperactivity, or impulsivity will be eligible for the study. All subjects will be Japanese, 18 years of age or older, and who have been judged by a physician to be fit to participate in the study.
2.Participant who has an informant who knows about your childhood.
3.Participant who have been fully informed .bout their participation in the study and have given their voluntary written consent to participate in the study with full understanding.

Key exclusion criteria

1.Participant who is deemed unsuitable as subjects by the principal investigator
2.Participant who has IQ less than 70 or a previous diagnosis of mental illness

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Takuya
Middle name
Last name Saito

Organization

Hokkaido University Hospital

Division name

Division of Child and Adolescent Psychiatry

Zip code

0608638

Address

North 14, West 5, Kita-ku, Sapporo, 060-8648, Hokkaido, Japan

TEL

+81-11-706-5160

Email

jidou@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Takuya
Middle name
Last name Saito

Organization

Hokkaido University Hospital

Division name

Department of Child and Adolescent Psychiatry

Zip code

0608638

Address

North 14, West 5, Kita-ku, Sapporo, 060-8648, Hokkaido, Japan

TEL

+81-11-706-5160

Homepage URL


Email

jidou@med.hokudai.ac.jp


Sponsor or person

Institute

Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Shionogi & Co., Ltd.
Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Faculty of Medicine, Hokkaido University

Address

Kita-ku, Kita 15, Nishi 7, Sapporo

Tel

+81-11-716-5003

Email

shomu@med.hokudai.ac.jp


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

北海道大学病院(北海道)


Other administrative information

Date of disclosure of the study information

2020 Year 10 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

Enrolling by invitation

Date of protocol fixation

2020 Year 10 Month 14 Day

Date of IRB

2020 Year 03 Month 01 Day

Anticipated trial start date

2020 Year 03 Month 01 Day

Last follow-up date

2021 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 10 Month 14 Day

Last modified on

2020 Year 10 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048072


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name