UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders
Acronym	The development of novel treatment using transcranial magnetic stimulation for patients with mood disorders
Scientific Title	An exploratory study for the development of novel individually optimized treatment using transcranial magnetic stimulation (TMS) for patients with mood disorders
Scientific Title:Acronym	The development of novel treatment using transcranial magnetic stimulation for patients with mood disorders
Region	Japan

Condition
Condition	Mood disorders (major depressive disorder and bipolar disorder) and healthy volunteers
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to identify changes in brain activity following TMS interventions against patients with mood disorder and to explore novel methodological approaches that effectively improve treatment effect
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Using psychological assessments and neuroimaging techniques, we evaluate psychological and neural changes in depression-related symptoms, immediately after the intervention, one week later, one month later, and again six months later.
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	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Other
Interventions/Control_1	For depressive patients, repetitive TMS will be applied with the following parameters below. Target location: left dorsolateral prefrontal cortex localized by a spatial navigation system Stimulation frequency: ~10Hz Stimulation intensity: ~120% of individual's resting motor threshold Number of pulses: 2000-3000 pulses/day Number of total sessions: 20-30 sessions
Interventions/Control_2	For healthy-control individuals, causally examine regionally interconnected brain regions by single-pulse TMS during a session (rather than after multiple sessions).
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	For patients/clients 1) Aged 20-80 years old 2) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM-IV-TR or DSM-5 3) Current diagnosis of major depressive episode 4) Present treatment-resistance (scores with 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after >=4 weeks of treatment with sufficient amount of more than1 anti-depressant) or low treatment-tolerance (insufficient administration due to side-effects while taking more than 1 anti-depressant) 5) Satisfactory informed consent obtained from participant him/herself For healthy control 1) Aged 20-80 years old 2) No history of any psychiatric disorders 3) Not having current serious medical illness 4) Satisfactory informed consent obtained from the participant him/herself
Key exclusion criteria	Rejection criteria common to both patients and healthy controls 1) Decisionally impaired individuals who has diminished capacity to understand the aim of the research 2) Physically impaired individuals who are not able to complete the experiments 3) Subjects who are contraindicated for the use of TMS and MRI Having an implanted heart pace-maker Having implanted cerebral (arteries) clips Having implanted neural/nerve stimulators Having implanted pumps Having work experience in a metal industry or possibility of metal residues remaining in the body Having metal-tattoos (including tattooed eye-lining) Being pregnant, or having possibility of being pregnant 4) Subjects who are contraindicated for the use of TMS Personal history of seizure disorder such as epileptic disorder 5) Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yasumasa Middle name Last name Okamoto
Organization	Graduate school of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Psychiatry and Neurosciences
Zip code	734-8551
Address	1-2-3 Kasumi, Minamiku, Hiroshima, 734-8553, Japan
TEL	082-257-5205
Email	oy@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Go Middle name Last name Okada
Organization	IGraduate school of Biomedical and Health Sciences, Hiroshima University
Division name	Department of Psychiatry and Neurosciences
Zip code	734-8551
Address	1-2-3 Kasumi, Minamiku, Hiroshima, 734-8553, Japan
TEL	082-257-5814
Homepage URL
Email	goookada@hiroshima-u.ac.jp

Sponsor
Institute	Department of Psychiatry and Neurosciences, Graduate school of Biomedical and Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Committee for Clinical Research of Hiroshima University
Address	1-2-3 Kasumi, Minamiku, Hiroshima
Tel	082-257-1551
Email	iryo-seisaku@office.hiroshima-u.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	2015 Year 10 Month 23 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	2015 Year 10 Month 20 Day
Date of IRB	2015 Year 10 Month 20 Day
Anticipated trial start date	2015 Year 11 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 10 Month 23 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021518