UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024769
Receipt number R000028494
Scientific Title Development of the Japanese Version of the Dimensional Obsessive-Compulsive Scale (DOCS)
Date of disclosure of the study information 2016/11/18
Last modified on 2019/03/02 01:39:48

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Basic information

Public title

Development of the Japanese Version of the Dimensional Obsessive-Compulsive Scale (DOCS)

Acronym

Development of the Japanese Version of the Dimensional Obsessive-Compulsive Scale (DOCS)

Scientific Title

Development of the Japanese Version of the Dimensional Obsessive-Compulsive Scale (DOCS)

Scientific Title:Acronym

Development of the Japanese Version of the Dimensional Obsessive-Compulsive Scale (DOCS)

Region

Japan


Condition

Condition

Obsessive-Compulsive Disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop the Japanese version of the Dimensional Obsessive-Compulsive Scale(DOCS) and investigate the reliability and the validity of this scale.

Basic objectives2

Others

Basic objectives -Others

To investigate the reliability and validity of the DOCS.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

DOCS

Key secondary outcomes

Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Obsessive Compulsive Inventory-Revised (OCI-R)
Liebowitz Social Anxiety Scale (LSAS)
Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder Quiestionnaire-7 (GAD-7)
Hoarding Rating Scale-self rating (HRS-SR)
Socio Economic Status (SES)


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Subjects who give full consent in the participation of this study.
2. Primary diagnosis of obsessive-compulsive disorder or other anxiety disorders

Key exclusion criteria

Individual with who have histories of substance abuse, active sucidality, severe mental and physical condition.

Target sample size

560


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akiko Nakagawa

Organization

Chiba University

Division name

Research Center for Child Mental Development

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba, Japan

TEL

0432262975

Email

akikon@chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Aki Tsuchiyagaito

Organization

Osaka University

Division name

United Graduate School of Child Development

Zip code


Address

1-8-1 Inohana, Chuo-kku, Chiba, Japan

TEL

0432262975

Homepage URL


Email

a-tsuchiyagaito@umin.ac.jp


Sponsor or person

Institute

Research Center for Child Mental Development, Chiba University

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

2016 Year 11 Month 18 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

The reliability and validity check of DOCS will be analyzed using this dataset.

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

2015 Year 12 Month 18 Day

Date of IRB


Anticipated trial start date

2016 Year 01 Month 22 Day

Last follow-up date

2018 Year 12 Month 31 Day

Date of closure to data entry

2018 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded



Other

Other related information

The questionnaire survey and the internet survey will be conducted.


Management information

Registered date

2016 Year 11 Month 08 Day

Last modified on

2019 Year 03 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028494


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name