UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028855 |
|---|---|
| Receipt number | 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 | 2024/03/03 09:10:08 |
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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
(1) Patients who are attending the outpatient department or inpatient ward of the Department of Neuropsychiatry, Keio University Hospital
(2) 18 years of age or older at the time of consent
(3) Patients whose attending physician determines that written consent can be obtained.
(4) Patients who meet the diagnostic criteria for depression according to the DSM-5 and the Mental Illness Inventory (MINI).
(5) Meet score 3 or higher on the Antidepressant Treatment History Form (ATHF) for the current episode or have not responded to two different types of antidepressant treatment in the past.
(6) Who demonstrate a severity of at least 18 points on the MADRS
(7) Have a stable mental status to the extent that they are able to undergo prolonged testing.
Key exclusion criteria
(1) Persons with cerebral organic diseases (e.g., intracranial organic lesions of moderate severity or higher, neurodegenerative diseases, etc.)
(2) History of convulsive seizures or epilepsy
(3) Substance-related disorders in the past 6 months
(4) Serious or unstable physical illness
(5) Undergone rTMS treatment or ECT within the past 6 months
(6) Any contraindication to TMS or MRI procedures such as metal implants, pacemakers, claustrophobia, etc.
(7) Patients whose head, neck, or body size is not suitable for MRI scanner
(8) Other cases that the principal investigator and subinvestigators deem inappropriate as research subjects
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
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
yoshi-tms@keio.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University School of Medicine
Institute
Department
Personal name
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）
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
Completed
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
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033026
