UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders
Title of the study (Brief title)	Effect of repetitive transcranial magnetic stimulation (rTMS)
Region	Japan

Condition
Condition	patients with depressive state who meet criteria for mood disorders or schizophrenia
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effectiveness of rTMS (real or sham stimulation) on brain morphology and function in patients with depressive state who meet criteria of mood disorders or schizophrenia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Hamilton Rating Scale for Depression
Key secondary outcomes	Beck Depression Inventory Brief Assesment of Cognition in Schizophrenia-Japanese version(BACS-J) brain MRI brain SPECT

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	1)real rTMS (20Hz), 2000 pulses per session 2)five treatment sessions per week during a period of four to six weeks
Interventions/Control_2	1)sham rTMS 2)five treatment sessions per week during a period of four to six weeks
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	1)patient with depressive state, who meets ICD-10 criteria for mood disorders or schizophrenia 2)non responder to medication for over half a year 3)20 years of age or over 4)gave written informed consent
Key exclusion criteria	1)past history of seizure 2)intracerebral metal 3)dependence on alcohol 4)serious cardiac disorder 5)cochlea implant 6)artificial cardiac pacemaker 7)infusion pump 8)any other patients who are regarded as unsuitable for this study by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Yuko Higuchi
Organization	University of Toyama
Division name	Department of Neuropsychiatry
Address	2630 Sugitani, Toyama
TEL	076-434-7323
Email	yhiguchi@med.u-toyama.ac.jp

Public contact
Name of contact person	Yuko Higuchi
Organization	University of Toyama
Division name	Department of Neuropsychiatry
Address	2630 Sugitani, Toyama
TEL	076-434-7323
Homepage URL
Email	yhiguchi@med.u-toyama.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Department of Neuropsychiatry, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

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	富山大学附属病院／Toyama University Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 09 Month 28 Day
Anticipated trial start date	2016 Year 12 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	2016 Year 11 Month 08 Day
Last modified on	2017 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028446