UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and feasibility study of Cognitive Behavioral Therapy for Obsessive Compulsive Disorder – an open-label pilot study
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masaru Horikoshi, Ph.D.
Organization	National Center of Neurology and Psychiatry
Division name	Cognitive Behavioral Therapy Center
Address	Ogawahigashi4-1-1, Kodaira, Tokyo, Japan
TEL	042-341-2712
Email	mhorikoshi@ncnp.go.jp

Public contact
Name of contact person	Masaru Horikoshi, Ph.D.
Organization	National Center of Neurology and Psychiatry
Division name	Cognitive Behavioral Therapy Center
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009881