UMIN-CTR Clinical Trial

Basic information
Public title	The Analysis for the Effect of Repetitive Transcranial Magnetic Stimulation in Depression
Acronym	rTMS
Scientific Title	The Analysis for the Effect of Repetitive Transcranial Magnetic Stimulation in Depression
Scientific Title:Acronym	rTMS
Region	Japan

Condition
Condition	Mental disorder with depressive state
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	the effects of rTMS on the brain activity in patients with depressive state were investigated
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction of depression
Key secondary outcomes	Near-Infrared Spectroscopy(NIRS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	repetitive Transcranial Magnetic Stimulation (rTMS) 4000pulses/day * 12days
Interventions/Control_2	sham stimulation 4000pulses/day * 12days
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients of mental disorder with depressive state They were classified fulfilling the criteria of International Statistical Classification of Diseases and Related Health Problems-10 (ICD-10)
Key exclusion criteria	History of seizures History of cerebral organic disease History of indwelling metal in the body History of drug abuse Pregnant
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Kawasaki
Organization	Kanazawa Medical University
Division name	Department of Neuro-Psychiatry
Zip code	920-0293
Address	1-1, Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, 920-0293, Japan
TEL	076-286-2211
Email	psychiat@kanazawa-med.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Okubo
Organization	Kanazawa Medical University
Division name	Department of Neuro-Psychiatry
Zip code	920-0293
Address	1-1, Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, 920-0293, Japan
TEL	076-286-2211
Homepage URL
Email	psychiat@kanazawa-med.ac.jp

Sponsor
Institute	Kanazawa Medical University Department of Neuro-Psychiatry
Institute
Department

Funding Source
Organization	Kanazawa Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kanazawa Medical University Hospital Clinical Reseach and Trials Center
Address	1-1, Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa, 920-0293, Japan
Tel	076-218-8347
Email	tiken@kanazawa-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	金沢医科大学病院（石川県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 22 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	Terminated
Date of protocol fixation	2017 Year 03 Month 22 Day
Date of IRB	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 04 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 22 Day
Last modified on	2022 Year 09 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030597