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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 2019/03/11

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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
Middle name
Last name Yoshihiro Noda
Organization Keio University School of Medicine
Division name Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email yoshi-tms@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Noda
Organization Keio University School of Medicine
Division name Neuropsychiatry
Zip code
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 Not entered
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 慶應義塾大学病院

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
2019 Year 03 Month 11 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
Registered date File name

Research case data
Registered date File name


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