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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043768
Receipt No. R000049946
Scientific Title A prospective observational study on efficacy and relapse prevention markers in repetitive transcranial magnetic stimulation therapy for depression
Date of disclosure of the study information 2021/03/29
Last modified on 2021/03/28

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Basic information
Public title A prospective observational study on efficacy and relapse prevention markers in repetitive transcranial magnetic stimulation therapy for depression
Acronym A prospective observational study on efficacy and relapse prevention markers in repetitive transcranial magnetic stimulation therapy for depression
Scientific Title A prospective observational study on efficacy and relapse prevention markers in repetitive transcranial magnetic stimulation therapy for depression
Scientific Title:Acronym A prospective observational study on efficacy and relapse prevention markers in repetitive transcranial magnetic stimulation therapy for depression
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Examination of efficacy and relapse prevention factors in repetitive transcranial magnetic stimulation therapy for depression
Basic objectives2 Others
Basic objectives -Others Examination of efficacy and relapse prevention factors in repetitive transcranial magnetic stimulation therapy for depression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy and relapse rate in transcranial magnetic stimulation therapy
Inflammatory and oxidative stress marker in peripheral blood
Electroencephalography
Head magnetic resonance imaging
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with treatment resistant depression who receive transcranial magnetic stimulation therapy
Key exclusion criteria Implanted electronic devices/magnetic material
Claustrophobia
Subjects who are judged as unsuitable for participation in this study by medical doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Shun
Middle name
Last name Takahashi
Organization Wakayama Medical University
Division name Department of Neuropsychiatry
Zip code 641-0012
Address Kimiidera 811-1, Wakayama
TEL 073-447-2300
Email cr-psy@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Shun
Middle name
Last name Takahashi
Organization Wakayama Medical University
Division name Department of Neuropsychiatry
Zip code 641-0012
Address Kimiidera 811-1, Wakayama
TEL 073-447-2300
Homepage URL
Email cr-psy@wakayama-med.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Research Ethics Committee of Wakayama Medical University
Address Kimiidera 811-1, Wakayama
Tel 073-447-2300
Email wa-rinri@wakayama-med.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
2021 Year 03 Month 29 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
2020 Year 07 Month 06 Day
Date of IRB
2020 Year 07 Month 06 Day
Anticipated trial start date
2021 Year 03 Month 29 Day
Last follow-up date
2025 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2021 Year 03 Month 28 Day
Last modified on
2021 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049946

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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