UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on predictive factors for therapeutic effect of rTMS on major depressive disorder
Title of the study (Brief title)	Predictive factors for therapeutic effect of rTMS on major depression
Region	Japan

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

Objectives
Narrative objectives1	To study predictive factors for therapeutic effect of rTMS (repetitive Transcranial Magnetic Stimulation) on major depressive disorder.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hamilton Depression Rating Scale (HAM-D)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	rTMS on the dorsolateral prefrontal cortex for 4 weeks
Interventions/Control_2	patients without rTMS
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with a DSM-5 diagnosis of major depressive disorder. The current depressive episode has a total score of at least 16 on the 17-item Hamilton Depression Rating Scale (HAM-D).
Key exclusion criteria	A history of other mental disorders; patients with a intracranial space-occupying lesion; patients with a history of head injury; patients with comorbid neurological disease; a personal or close family history of a seizure disorder; patients who develop epileptiform discharge on EEG; pregnancy; presence of physical disease or medication therapy known to alter seizure threshold presence of ferromagnetic material in or in close proximity to the head; presence of ferromagnetic material in the body; patients with emergent suicidal ideation; patients with stupor; patients who received electroconvulsive therapy in the past month; patients with substance/medication-induced depressive disorder; patients with depressive disorder due to another medical conditions.
Target sample size	20

Research contact person
Name of lead principal investigator	Nishimura, Isao
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Psychiatry
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5033
Email	inishimu@koto.kpu-m.ac.jp

Public contact
Name of contact person	Nishimura, Isao
Organization	Kyoto Prefectural University of Medicine
Division name	Department of Psychiatry
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan
TEL	075-251-5033
Homepage URL
Email	inishimu@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization	Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	京都府立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 16 Day
Last modified on	2018 Year 07 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022861