UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010107 |
|---|---|
| Receipt number | R000011841 |
| Scientific Title | Cognitive neuroscience study of dissociative disorder |
| Date of disclosure of the study information | 2013/02/24 |
| Last modified on | 2013/02/24 13:09:33 |
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Basic information
Public title
Cognitive neuroscience study of dissociative disorder
Acronym
Dissociative disorder
Scientific Title
Cognitive neuroscience study of dissociative disorder
Scientific Title:Acronym
Dissociative disorder
Region
| Japan |
Condition
Condition
dissociative disorder and conversion disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify brain functions associated with dissociative and conversion symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BOLD signals in brain regions associated with vision, motion, language, memory, and attention; EEG; SCRs; MEG.
Key secondary outcomes
Association between primary outcomes with symptoms
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
functional MRI
structural MRI
psychophysiological measurements
Interventions/Control_2
symptoms
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients
- Those who are diagnosed as dissociative disorder or conversion disorder based on DSM-IV-TR.
- Those who can understand the instruction and agree on the written consent. Two psychiatrists judge the patient's ability of consent.
Healthy subjects
- Those who can understand the instruction and agree on the written consent.
Key exclusion criteria
Patients
- Those who have a history of neurological disorders, such as brain injuries, parkinson disease, etc.
- Those who have a history of serious physical disorders.
Healthy subjects
- Those who have a history of serious physical disorders, neurological disorders, and psychiatric disorders including drug dependence and serious medical illness.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Yamada |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1 Anagawa, Inageku, Chiba
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2013 | Year | 02 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 24 | Day |
Last modified on
| 2013 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011841
