UMIN-CTR Clinical Trial

Basic information
Public title	Development of a new transcranial magnetic stimulation therapy for treatment-resistant depression and identification of its predictor of response
Acronym	Development of a new form of rTMS treatment for TRD
Scientific Title	Development of a new transcranial magnetic stimulation therapy for treatment-resistant depression and identification of its predictor of response
Scientific Title:Acronym	Development of a new form of rTMS treatment for TRD
Region	Japan North America

Condition
Condition	Treatment-resistant depression(TRD)
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we aim to develop a novel transcranial magnetic stimulation (rTMS) therapy for acute and maintenance phase of treatment-resistant depression (TRD) and to identify its neurobiological therapeutic mechanism. Specifically, we aim to develop a novel form of rTMS protocol, which has higher or at least equivalent therapeutic effect, preventive effect on relapse/recurrence, and acceptability, including safety, compared to the conventional form of rTMS treatment in patients with TRD. In addition, we aim to identify biological predictors of response, as well as to investigate the therapeutic mechanisms by this novel form of rTMS protocol in this population.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	All participants will received the following measures at time . Montgomery Asberg Depression Rating Scale (MADRS), 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J) Maintenance phase: Montgomery Asberg Depression Rating Scale (MADRS), 16-item Quick Inventory of Depressive Symptoms-Japanese version (QIDS16-J)
Key secondary outcomes	Acute phase: 17-Item Hamilton Rating Scale for Depression (HRSD-17), Brief Symptom Inventory-anxiety subscale (BSI-anxiety), Beck Suicide Scale for Suicide Ideation (BSS), Pittsburgh Sleep Quality Index (PSQI) Montreal Cognitive Assessment (MoCA), California Verbal Learning Test Second Edition (CVLT-II), Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Letter Number Sequencing Test (LNST), Stroop Neuropsychological Screening Test (SNST), Trail Making Test (TMT), The Executive Interview (EXIT25) Resting-state EEG (rs-EEG), MRI (T1, resting-state fMRI (rs-fMRI), DTI, MRS), Polysomnography (PSG), Holter ECG, Capillary Electrophoresis Mass Spectrometry (CE-MS), Liquid Chromatography Mass Spectrometry (LC-MS) Maintenance phase: 17-Item Hamilton Rating Scale for Depression (HRSD-17), Brief Symptom Inventory-anxiety subscale (BSI-anxiety) Resting-state EEG (rs-EEG), Auditory Steady State Response (ASSR), Capillary Electrophoresis Mass Spectrometry (CE-MS), Liquid Chromatography Mass Spectrometry (LC-MS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Conventional sequential bilateral rTMS treatment
Interventions/Control_2	Novel sequential bilateral theta-burst stimulation rTMS treatment
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Not entered
Key exclusion criteria	Not entered
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Noda
Organization	Keio University School of Medicine
Division name	Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Email	yoshi-tms@keio.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Noda
Organization	Keio University School of Medicine
Division name	Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-3353-1211
Homepage URL	http://psy.keiomed.jp/mtr-lab_mri-tms-eeg.html
Email	yoshi-tms@keio.jp

Sponsor
Institute	Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department

Funding Source
Organization	TEIJIN PHARMA LIMITED.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Japan Agency for Medical Research and Development
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Independent Ethics Committee, Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	0333531211
Email	med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs032180188
Org. issuing International ID_1	Certified Review Board, Keio University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 19 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	Open public recruiting
Date of protocol fixation	2017 Year 08 Month 28 Day
Date of IRB	2018 Year 02 Month 07 Day
Anticipated trial start date	2018 Year 02 Month 07 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 08 Month 28 Day
Last modified on	2020 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033026

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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