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
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
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
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
