UMIN-CTR Clinical Trial

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
Email	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
Email	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

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)
Email	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
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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