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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001726
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kyushu University
Institute
Department

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
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

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
URL(English) https://upload.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


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