UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038758 |
|---|---|
| Receipt number | R000044180 |
| Scientific Title | Longitudinal MRI study Identifying the Neural Substrates of Remission/Recovery in Mood Disorders |
| Date of disclosure of the study information | 2019/12/02 |
| Last modified on | 2019/12/18 15:09:55 |
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Basic information
Public title
Longitudinal MRI study Identifying the Neural Substrates of Remission/Recovery in Mood Disorders
Acronym
L/R Study
Scientific Title
Longitudinal MRI study Identifying the Neural Substrates of Remission/Recovery in Mood Disorders
Scientific Title:Acronym
L/R Study
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are: (1) to investigate the underlying biological mechanisms of representative treatments for depressive state (i.e., pharmacological treatment, cognitive behavioral therapy (CBT), repetitive transcranial magnetic stimulation (rTMS), and electroconvulsive therapy (ECT)); (2) to investigate changes in neural circuits common or specific to each treatment; and (3) to elucidate biological predictors for each treatment.
Basic objectives2
Others
Basic objectives -Others
We examine brain functional or structural alterations with clinical improvements in four therapeutic interventions and identify the neural networks specific to treatment response in each treatment. By applying a machine learning technique to individual data, including MRI data, data on participants' backgrounds, and clinical data, we aim to develop a novel model that accurately predicts treatment response and course trajectory in mood disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain structural and functional data based on 3D-T1 imaging (sMRI) and resting-state functional MRI (rs-fMRI)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were as follows: those who 1) met the criteria for a depression/major depressive disorder or persistent depressive disorder under DSM-5 diagnostic guidelines; 2) were scheduled to undergo electroconvulsive therapy, cognitive behavioral therapy, psychopharmaco therapy, or repetitive transcranial magnetic stimulation; 3) can understand the purpose and content of this study and express written consent to participate in this study based on their will; and 4) scored more than 8 points on the Hamilton Rating Scale for Depression.
Key exclusion criteria
Exclusion criteria were as follows: those who 1) had a history of drug or alcohol misuse within two years; 2) demonstrate manic episodes; 3) currently have suicidal ideation or have attempted suicide in the past; 4) have antisocial personality disorder; 5) will become unable to continue visiting the hospital (e.g., moving away); 6) have reported an unstable medical condition or history of significant head trauma; 7) are unable to undergo MRI scans due to metal in the body; 8) have claustrophobia; 9) are judged otherwise unsuitable for this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura, |
Organization
Keio University, School of Medicine
Division name
Psychiatry
Zip code
160-0016
Address
35 Sinanomachi Shinjyuku Tokyo
TEL
03-5379-0187
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Jinichi |
| Middle name | |
| Last name | Hirano |
Organization
Keio University, School of Medicine
Division name
Psychiatry
Zip code
160-0016
Address
35 Sinanomachi Shinjyuku Tokyo
TEL
03-5379-0187
Homepage URL
hjinichi@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Research Ethics Committee of Keio university, school of medicine
Address
35 Sinanomachi Shinjyuku Tokyo
Tel
+81.3.3353.1211(x62014)
med-rinri-jimu@adst.keio.ac.jp
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
| 2019 | Year | 12 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a multicenter (Keio University, Kyoto University, National center of Neurology and psychiatry), open study based on usual care, and the observation period is about 7-10 months in principle. Patients who will receive any one of four treatments (pharmacotherapy, cognitive behavioral therapy, electroconvulsive therapy, and repetitive transcranial magnetic stimulation) are recruited as potential subjects, and a healthy group is also recruited.
MRI scans and clinical evaluations are conducted three times: once each within two-week periods before and after treatment, and once six months after treatment.
Management information
Registered date
| 2019 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044180
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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