UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Acronym	Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Scientific Title	Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Scientific Title:Acronym	Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Region	Japan

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

Objectives
Narrative objectives1	To investigate the mechanism of recovery from depression following rTMS and the potential predictors of treatment response
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Near Infrared Spectroscopy (NIRS), MRI, and psychological tests
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Left dorsolateral prefrontal cortex high-frequency rTMS, or, right dorsolateral prefrontal cortex low-frequency rTMS
Interventions/Control_2	Patients without rTMS
Interventions/Control_3	Healthy volunteers without rTMS
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are diagnosed as major depressive disorder or bipolar disorder according to SCID, and healthy volunteers without psychiatric disorders
Key exclusion criteria	Subjects who are contraindicated for the use of MRI Subjects do not have capability of informed consent Subjects who are judged as unsuitable for participation in this study Concerning the patients with rTMS, patients who are contraindicated for rTMS are excluded.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshiyuki Middle name Last name Yamashita
Organization	Kyoto Prefectural Rakunan Hospital
Division name	Department of Psychiatry
Zip code	611-0011
Address	2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan
TEL	0774-32-5900
Email	rakunanhp-shomu@pref.kyoto.lg.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Yamasaki
Organization	Kyoto Prefectural Rakunan Hospital
Division name	Department of Psychiatry
Zip code	611-0011
Address	2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan
TEL	0774-32-5900
Homepage URL
Email	rakunanhp-shomu@pref.kyoto.lg.jp

Sponsor
Institute	Kyoto Prefectural Rakunan Hospital
Institute
Department

Funding Source
Organization	Kyoto prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Rakunan Hospital Ethics Committee
Address	2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan
Tel	0774-32-5900
Email	rakunanhp-shomu@pref.kyoto.lg.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	洛南病院（京都府）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 02 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	81
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	2013 Year 09 Month 02 Day
Date of IRB	2013 Year 10 Month 01 Day
Anticipated trial start date	2013 Year 11 Month 06 Day
Last follow-up date	2019 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study was approved by the Ethics Committee at Kyoto Prefectural Rakunan Hospital under the title of "Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and neural responses following rTMS in major depression". The data partially overlap with the data in the study entitled "Neural responses following transcranial magnetic stimulation (rTMS) in major depression (UMIN000013493)"

Management information
Registered date	2015 Year 01 Month 31 Day
Last modified on	2019 Year 08 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019033