UMIN-CTR Clinical Trial

Basic information
Public title	A preliminary study of a predictor of treatment response to transcranial magnetic stiumulation in treatment-resistant depression
Acronym	Transcranial magnetic stiumulation in treatment-resistant depression
Scientific Title	A preliminary study of a predictor of treatment response to transcranial magnetic stiumulation in treatment-resistant depression
Scientific Title:Acronym	Transcranial magnetic stiumulation in treatment-resistant depression
Region	Japan

Condition
Condition	Treatment-resistant depression
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of efficacy of and exploration and identification of a predictor of treatment response to transcranial magnetic stimulation in treatment-resistant depression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of depressive symptoms from the start point to eight weeks later
Key secondary outcomes

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	Transcranial magnetic stimulation, dorsolateral prefrontal cortex, 4 weeks, 10 Hz, 100-120% MT (motor threshold), 4 sec, 3000 pulsed/day, 5 days/week
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Diagnosed as major depression by DSM-5 Larger than 14 in the score of HAMD 17 Less than three years in the period of the most recent depressive episode Treatment-resistant in the present depressive episode
Key exclusion criteria	History of psychotic episode, bipolar disorder, obsessive-compulsive disorder, PTSD, or eating disorder History of treatment of ECT, TMS, VNS, DBS, or tDCS Pregnancy History of convulsive disorder including epilepsy History of neurological or organic brain disease Diagnosed as drug or alcohol dependence Magnetic substance in a body including pace-maker, cochlear implant, or intracranial clip Having severe state of diseases of endocrine or metabolic system Having severe level of suicide idea Treated with the medicines which taper the convulsion thresholds
Target sample size	24

Research contact person
Last name of lead principal investigator	1st name Mamoru Middle name Last name Tochigi
Organization	Teikyo University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	173-8605
Address	2-11-1, Kaga, Itabashi
TEL	03-3964-1211
Email	mtoc-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Mamoru Middle name Last name Tochigi
Organization	Teikyo University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	173-8605
Address	2-11-1, Kaga, Itabashi
TEL	03-3964-1211
Homepage URL
Email	mtoc-tky@umin.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Teikyo University Ethics Committee
Address	2-11-1, Kaga, Itabashi
Tel	03-3964-7256
Email	turb-office@teikyo-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	2017 Year 02 Month 14 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	15
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	2017 Year 02 Month 07 Day
Date of IRB	2013 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 02 Month 15 Day
Last follow-up date	2019 Year 02 Month 27 Day
Date of closure to data entry	2019 Year 02 Month 27 Day
Date trial data considered complete	2019 Year 02 Month 27 Day
Date analysis concluded	2019 Year 02 Month 27 Day

Other
Other related information

Management information
Registered date	2017 Year 02 Month 14 Day
Last modified on	2019 Year 03 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029909