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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008403
Receipt No. R000009881
Scientific Title Safety and feasibility study of Cognitive Behavioral Therapy for Obsessive Compulsive Disorder – an open-label pilot study
Date of disclosure of the study information 2012/07/17
Last modified on 2016/07/11

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Basic information
Public title Safety and feasibility study of Cognitive Behavioral Therapy for Obsessive Compulsive Disorder – an open-label pilot study
Acronym Cognitive Behavioral Therapy for Obsessive Compulsive Disorder-an open-label pilot study
Scientific Title Safety and feasibility study of Cognitive Behavioral Therapy for Obsessive Compulsive Disorder – an open-label pilot study
Scientific Title:Acronym Cognitive Behavioral Therapy for Obsessive Compulsive Disorder-an open-label pilot study
Region
Japan

Condition
Condition Obsessive Compulsive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test safety and feasibility of Cognitive Behavioral Therapy for Obsessive Compulsive Disorder in Japanese clinical settings
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Y-BOCS (Yale-Brown Obsessive Compulsive Scale)
Key secondary outcomes BDI-II(Beck Depression Inventory)
SF-36(Quality of Life Scale)
OASIS(Overall Anxiety Severity and Impairment Scale)
EQ5D(Quality of Life Scale)
QIDS-J(Quick Inventory of Depressive Symptomatology)
GRID-HAMD(GRID-Hamilton Depression Rating Scale)
MRI

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 Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Cognitive Behavioral Therapy for Obsessive Compulsive Disorder
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects with current DSM-IV Obsessive Compulsive Disorder at screening.
2. Aged 20 years or order, and 65 years or younger at screening.
3. Subjects who give full consent in the participation of the study.
Key exclusion criteria 1. No alcohol or substance use disorder in 6 months prior to the screening.
2. No other primary DSM-IV Axis I Disorders except Obsessive Compulsive Disorder in 6 months prior to the screening.
3. No comorbid of antisocial personality disorder.
4. No serious suicidal ideation at screening.
5. Evidence of unable to participate half or more of the intervention phase.
6. No past treatment of CBT for Obsessive Compulsive Disorder.
7. No major cognitive deficits for CBT treatment at screening.
8. No severe or unstable medical co-morbidities at screening.
9. Other relevant reason decided by the investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Horikoshi, Ph.D.
Organization National Center of Neurology and Psychiatry
Division name Cognitive Behavioral Therapy Center
Zip code
Address Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL 042-341-2712
Email mhorikoshi@ncnp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Horikoshi, Ph.D.
Organization National Center of Neurology and Psychiatry
Division name Cognitive Behavioral Therapy Center
Zip code
Address Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL 042-341-2712
Homepage URL
Email mhorikoshi@ncnp.go.jp

Sponsor
Institute Cognitive Behavioral Therapy Center OCD Study Group
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 独立行政法人国立精神・神経医療研究センター病院

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 17 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
2012 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 11 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2013 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 11 Day
Last modified on
2016 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009881

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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