UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility study of transcranial magnetic stimulation for resistant major depressive episode
Title of the study (Brief title)	The feasibility study of transcranial magnetic stimulation for resistant major depressive episode
Region	Japan

Condition
Condition	major depressive disorder, bipolar disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the feasibility and preliminary efficacy of transcranial magnetic stimulation for resistant major depressive episode
Basic objectives2	Others
Basic objectives -Others	Feasibility
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Adherence to treatment
Key secondary outcomes	1)Beck Depression Inventry II(BDI-II) 2)Hamilton Depression Rating Scale (Ham-D) 17items 3)Montgomery Asberg Depression Scale (MADRS) 4)Frequency,Intensity, and Burden of Side Effects Rating (FIBSER) 5)Young Manic Rating Scale (YMRS)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Low-frequency rTMS to the right dorsolateral prefrontal cortex or High-frequency rTMS to the left dorsolateral prefrontal cortex
Interventions/Control_2
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)DSM-IV-TR diagnosis of major depressive disorder (MDD) or bipolar disorder (BD) 2)Hamilton Scale for Depression 17-item score: 14 or more 3)Medication resistance(Insufficient clinical improvement of MDD from at least two antidepressant trials/ Insufficient clinical improvement of BD from lithium or lamotrigine and atypical antipsychotic treatment ) 4)Capability of informed consent 5)Aged 20 years old or more
Key exclusion criteria	1)Other Axis I disorders 2)Axis II disorders 3)Seizure-inducing disease (brain tumor, head injury, etc.) 4)Neurologic disorder, organic brain disorder 5)History of seizure 6)Paroxysmal EEG abnormality 7)Pregnancy 8)Ferromagnetic material in head(except oral cavity) 9)Patients with a pacemaker 10)Active suicide idea 11)Stupor state 12)Previous treatment with electroconvulsive therapy within one month 13)Depressive patients related to physical diseases or drugs 14)Family members of researchers 15)Patients likely to change to another hospital within 6 months 16)Patients judged to be not appropriate for participation in this study by the physician 17) Patients who do not understand Japanese
Target sample size	20

Research contact person
Name of lead principal investigator	Seishi Terada
Organization	Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name	Department of Neuropsychiatry
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL	086-235-7246
Email	terada@cc.okayama-u.ac.jp

Public contact
Name of contact person	Masatoshi Inagaki
Organization	Okayama University Hospital
Division name	Department of Neuropsychiatry
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL	086-235-7246
Homepage URL
Email	masatoshiinagaki@med.okayama-u.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Institute
Department

Funding Source
Organization	Okayama University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Okayama Psychiatric Medical Center
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

Other administrative information
Date of disclosure of the study information	2014 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 19 Day
Anticipated trial start date	2014 Year 04 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	2014 Year 03 Month 28 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014416