UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008403 |
|---|---|
| Receipt number | 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 12:27:57 |
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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
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
mhorikoshi@ncnp.go.jp
Sponsor or person
Institute
Cognitive Behavioral Therapy Center OCD Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009881
