UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023104 |
|---|---|
| Receipt number | R000026627 |
| Scientific Title | Functional MRI study of treatment mechanisms of Eye Movement Desensitization and Reprocessing in Posttraumatic stress disorder |
| Date of disclosure of the study information | 2016/07/15 |
| Last modified on | 2019/01/04 12:20:49 |
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Basic information
Public title
Functional MRI study of treatment mechanisms of Eye Movement Desensitization and Reprocessing in Posttraumatic stress disorder
Acronym
Functional MRI study of treatment mechanisms of EMDR in PTSD
Scientific Title
Functional MRI study of treatment mechanisms of Eye Movement Desensitization and Reprocessing in Posttraumatic stress disorder
Scientific Title:Acronym
Functional MRI study of treatment mechanisms of EMDR in PTSD
Region
| Japan |
Condition
Condition
Posttraumatic stress disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of PTSD and treatment mechanisms of EMDR
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain function with fMRI during a script-driven imagery task before and after EMDR treatment
Key secondary outcomes
Clinician-Administered PTSD
Dessosiative Experiences Scale-2
Impact of Event Scale-revised
Beck Depression Inventory-2
State-Trait Anxiety Inventory
Posttraumatic Cognition Inventory
Posttraumatic Growth Inventory
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
fMRI measurements during the script-driven imagery task and EMDR treatment/Patients with PTSD
Interventions/Control_2
fMRI measurements during the script-driven imagery task/Normal controls
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.To meet the diagnostic criteria for Posttraumatic stress disorder in DSM-5 as a primary diagnostic
2.Aged 18 to 65 years old
3.Subjects who have signed consent to participate in this study
Key exclusion criteria
1.Prior treatment of EMDR.
2.Subjects who have any other current DSM-5 diagnosis of the following;"Neurodvelopmental Disorders","Schizophrenia Spectrum and other Psychotic Disorders","Bipolar and Related Disorders","Feeding and Eating Disorders","Substance-Related and Addictive Disorders","Neurocognitive Disoreders".
3.Subjects who have a diagnosis of a severe physical disorder.
4.Women during pregnancy, possible pregnancy.
5.Subjects who have serious suicidal ideation.
6.Subjects with metallic device in their body.
7.Inappropriate patients for this study judged by physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SHU TAKAGAI |
Organization
Hamamatsu University School of Medicine
Division name
Department of Child and Adolescent Psychiatry
Zip code
Address
1-20-1 Handayama,Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2058
takagai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | JUN INOUE |
Organization
Hamamatsu University School of Medicine
Division name
Department of Child and Adolescent Psychiatry
Zip code
Address
1-20-1 Handayama,Hamamatsu, Shizuoka 431-3192, Japan
TEL
053-435-2295
Homepage URL
juninoue@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 07 | Month | 15 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 30 | 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
| 2016 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026627
