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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023104
Receipt No. 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

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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
Email 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
Email juninoue@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026627

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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