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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000038758 |
Receipt No. | 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 | 2019/12/02 |
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 |
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Condition | ||
Condition | Major depressive disorder | |
Classification by specialty |
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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)) and (2) 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, their background, 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 | |
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Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
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Gender | Male and Female | |||
Key inclusion criteria | Inclusion criteria were as follows: those who 1)who met the criteria for a major depressive disorder according to DSM-5, 2) who were scheduled to undergo electroconvulsive therapy or CBT or psychopharmaco thearapy or TMS,3)who showed more than 8 point on the Hamilton Rating Scale for Depression. | |||
Key exclusion criteria | Exclusion criteria were as follows: those who 1) had a lifetime history of drug or alcohol misuse, 2) who show manic episodes, 3) who have suicidal ideation, 4) antisocial personality Disorder, 5)reported an unstable medical condition or history of significant head trauma, 6) who had implanted metal in the body, 7) who had claustrophobia
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Target sample size | 500 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Keio University |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development (AMED) |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Results | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Other | |
Other related information | In the current study, we performed a large scale, multi-site(Keio University, Kyoto University, National center of Neurology and psychiatry), longitudinal magnetic resonance imaging (MRI) study to investigate the neural substrates of remission/recovery, and to identify a prediction model for treatment (pharmacotherapy, CBT, rTMS, and ECT) response/relapse in mood disorder patients.
MRI scans and clinical evaluation are conducted three times, pre/post treats,ent, and 6 months after treatment. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044180 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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