UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027853
Receipt number R000031869
Scientific Title Development of a predictive model for compulsions in obsessive-compulsive disorder
Date of disclosure of the study information 2017/06/26
Last modified on 2017/10/16 14:35:56

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Basic information

Public title

Development of a predictive model for compulsions in obsessive-compulsive disorder

Acronym

Development of a predictive model for compulsions

Scientific Title

Development of a predictive model for compulsions in obsessive-compulsive disorder

Scientific Title:Acronym

Development of a predictive model for compulsions

Region

Japan


Condition

Condition

obsessive-compulsive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop a predictive model for compulsions in obsessive-compulsive disorder based on mathematical theory.

Basic objectives2

Others

Basic objectives -Others

In this study some stimulus will be presented to patients with obsessive-compulsive disorder to induce their symptoms. The number and duration of compulsions will be measured as well as physiological index such as body pressure, pulse rate, breathing rate before and after presentation of stimulus. Relationship among them will be analyzed based on mathematical theory and a predictive model for compulsion will be developed as a new assessment tool for symptom severity.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The number and duration of compulsions after presentation of stimulus

Key secondary outcomes

Body pressure, pulse rate, breathing rate before and after presentation of stimulus


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Present three stimulus to induce compulsions

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The inclusion criteria for patients are (1)patients with obsessive-compulsive disorder treated at Kyoto Prefectural University of Medicine Hospital, Kyoto, Japan, and (2) the ability to give written, informed consent after receiving a complete description of the study.

Key exclusion criteria

Patients who are under 20 years old

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Nakamae

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Department of Psychiatry

Zip code


Address

Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan

TEL

075-251-5612

Email

nakamae@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Nakamae

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Department of Psychiatry

Zip code


Address

Kajii-cho 465, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566, Japan

TEL

075-251-5612

Homepage URL


Email

nakamae@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

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

2017 Year 06 Month 26 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

Completed

Date of protocol fixation

2017 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2017 Year 06 Month 26 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

2017 Year 06 Month 21 Day

Last modified on

2017 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031869


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name