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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000028855 |
Receipt No. | R000033026 |
Scientific Title | Development of a new transcranial magnetic stimulation therapy for treatment-resistant depression and identification of its predictor of response |
Date of disclosure of the study information | 2018/01/19 |
Last modified on | 2020/03/02 |
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 | ||
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Condition | ||
Condition | Treatment-resistant depression(TRD) | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Conventional sequential bilateral rTMS treatment | |
Interventions/Control_2 | Novel sequential bilateral theta-burst stimulation rTMS treatment | |
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Eligibility | ||||
Age-lower limit |
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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 |
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Organization | Keio University School of Medicine | ||||||
Division name | Neuropsychiatry | ||||||
Zip code | 160-8582 | ||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo | ||||||
TEL | 03-3353-1211 | ||||||
yoshi-tms@keio.jp |
Public contact | |||||||
Name of contact person |
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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 | ||||||
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 |
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) |
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Date of disclosure of the study information |
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URL releasing protocol | |
Publication of results | Unpublished |
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Recruitment status | Open public recruiting | ||||||
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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=R000033026 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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