UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001726 |
|---|---|
| Receipt number | R000002075 |
| Scientific Title | A randomized controlled trial of patients with obsessive-compulsive disorder: A functional magnetic resonance imaging study |
| Date of disclosure of the study information | 2009/02/22 |
| Last modified on | 2009/02/22 16:42:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A randomized controlled trial of patients with obsessive-compulsive disorder: A functional magnetic resonance imaging study
Acronym
A functional MRI study of patients with OCD
Scientific Title
A randomized controlled trial of patients with obsessive-compulsive disorder: A functional magnetic resonance imaging study
Scientific Title:Acronym
A functional MRI study of patients with OCD
Region
| Japan |
Condition
Condition
obsessive-compulsive disorder(OCD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of behavior therapy and fluvoxamine in patients with OCD, using functional MRI
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (after the 12-week treatment)
functional activation maps (before and after treatment)
Neuropsychological tests (attention, executive function, memory)
Key secondary outcomes
Hamilton Depressive Rating Scale (HDRS)
State-Trait Anxiety Inventory (STAI)
(after the 12-week treatment)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Fluvoxamine, up to a dose of 200mg/day,
Autogenic Training (a psychological placebo), once a week
for 12 weeks
Interventions/Control_2
pill placebo
behavior therapy, once a week
for 12 weeks
Interventions/Control_3
pill placebo
Autogenic Training (a psychological placebo), once a week
for 12 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria for patients were aged from 18 to 60 years old and primary OCD diagnosis that was confirmed by the psychosis subsection of the structured clinical interview of DSM-IV.
Key exclusion criteria
comorbid axis I diagnosis
neurological disorder
head injury
serious medical condition
history of drug/alcohol addiction
a total y-BOCS score lower than 16
a HDRS score more than 18 points
a total IQ of less than 80
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenobu Kanba |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Neuropsychiatry
Zip code
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Nakao |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Neuropsychiatry
Zip code
Address
3-1-1 Maidashi Higashi-ku, Fukuoka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
the Japanese Ministry of Education, Culture, Sports, Science and Technology
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Nakao T, Nakagawa A, Yoshiura T, Nakatani E, Nabeyama M, Yoshizato C, et al. (2005): Brain activation of patients with obsessive-compulsive disorder during neuropsychological and symptom provocation tasks before and after symptom improvement: a functional magnetic resonance imaging study. Biological psychiatry. 57:901-910.
Nakao T, Nakagawa A, Yoshiura T, Nakatani E, Nabeyama M, Yoshizato C, et al. (2005): A functional MRI comparison of patients with obsessive-compulsive disorder and normal controls during a Chinese character Stroop task. Psychiatry research. 139:101-114.
Nakatani E, Nakagawa A, Nakao T, Yoshizato C, Nabeyama M, Kudo A, et al. (2005): A randomized controlled trial of Japanese patients with obsessive-compulsive disorder--effectiveness of behavior therapy and fluvoxamine. Psychotherapy and psychosomatics. 74:269-276.
Nabeyama M, Nakagawa A, Yoshiura T, Nakao T, Nakatani E, Togao O, et al. (2008): Functional MRI study of brain activation alterations in patients with obsessive-compulsive disorder after symptom improvement. Psychiatry research. 163:236-247.
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
| 2001 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 22 | Day |
Last modified on
| 2009 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002075
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
