UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013113
Receipt number R000015301
Scientific Title The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,
Date of disclosure of the study information 2014/02/09
Last modified on 2015/08/09 09:48:06

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Basic information

Public title

The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,

Acronym

The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,

Scientific Title

The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,

Scientific Title:Acronym

The effect of meta-behavior therapy in obsessive compulsive disorder using both a voxel-based morphometry approach and neuropsychological tasks,

Region

Japan


Condition

Condition

obsessive compulsive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we examined the existence of regional structural abnormalities in both the gray matter (GM) and the white matter (WM) of patients with OCD at baseline using a voxel-based morphometry (VBM) approach in responders and non-responders to subsequent meta BT.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The difference of regional structural abnormalities in both GM and WM at baseline using an optimized VBM approach in both responders and non-responders to meta-BT

Key secondary outcomes

Neuropsychological tasks


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

Meta Cognitive Behavioral therapy

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

60 years-old >=

Gender

Male and Female

Key inclusion criteria

Japanese patients with OCD were recruited at Nagoya City University Hospital. Diagnoses were made based on structured interviews conducted by trained psychiatrists using the Structured Clinical Interview for DSM-IV Patient Version (SCID-P).

Key exclusion criteria

There was a previous history of mental illness or substance abuse, the patient has pacemaker, other findings in terms with the aims of this study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shutaro Nakaaki

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Psychiatry and Cognitive-Behavioral Medicine

Zip code


Address

Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN

TEL

052-853-8271

Email

hzi05510@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Nobuhiko Hashimoto

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Psychiatry and Cognitive-Behavioral Medicine

Zip code


Address

Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN

TEL

052-853-8271

Homepage URL


Email

hashinobu@nifty.com


Sponsor or person

Institute

Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

none

Name of secondary funder(s)

none


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

名古屋市立大学大学院医学研究科 精神・認知・行動医学分野


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 09 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

2013 Year 03 Month 19 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 09 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 02 Month 09 Day

Last modified on

2015 Year 08 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015301


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name