UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial
Title of the study (Brief title)	Efficacy and safety of dTMS in treatment-resistant MDD and BD
Region	Japan

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

Objectives
Narrative objectives1	To examine the efficacy of deep TMS in patients with treatment-resistant depression or bipolar depression who does not respond to a return to work program
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in the total HDRS-21 score
Key secondary outcomes	The rates of response and remission, changes in cognitive function, and NIRS

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	High-frequency left prefrontal dTMS, 5 days per week, for 4 to 6 weeks
Interventions/Control_2	Sham stimulation, 5 days per week, for 4 to 6 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	25 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients who does not respond to a return to work program 2)MDD or bipolar disorder 3)HDRS-21 score is not changed by 6 point or more after 6 weeks of treatment with fixed regimen of medication and/ or psychotherapy 4)Total HDRS-21 >=20 at baseline
Key exclusion criteria	1)Enable to determine MT 2)Depression secondary to a general medical condition, or substance-induced 3)History of substance abuse or dependence within the past 6 months (except nicotine and caffeine) 4)Schizophrenic disorder or schizoaffective disorder 5)Major depression with psychotic features in the current episode 6)Individuals with a significant neurological disorder or insult including any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure, history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, mini Mental State Exam score of less than or equal to 24, Parkinson's disease, Huntington's chorea, multiple sclerosis) 7)Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness or personal history of epilepsy 8)Individuals with hearing loss 9)History of ECT treatment 10)Treatment with rTMS therapy 11)Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4 or a history of attempted suicide in the last 3 years. 12)Any self-inflicted harm in the past 13)Implantation of metal object in upper body 14)Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease 15)Implanted neurostimulators 16)History of abnormal MRI 17)Women who are pregnant or breast-feeding 18)Clinically significant laboratory abnormality, in the opinion of the investigator based on CBC and biochemistry
Target sample size	40

Research contact person
Name of lead principal investigator	Shinsuke Kito
Organization	National Center Hospital, National Center of Neurology and Psychiatry
Division name	Department of Psychiatry and Advanced Medical Technology
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL	042-341-2711
Email	kito@ncnp.go.jp

Public contact
Name of contact person	Toshihide Hayashi
Organization	Medical Care Toranomon
Division name	Medical Care Toranomon
Address	1-16-16 Toranomon, Minatoku, Tokyo 105-0001, Japan
TEL	03-5510-3898
Homepage URL
Email	dtms@medcare-tora.com

Sponsor
Institute	Medical Care Toranomon
Institute
Department

Funding Source
Organization	Medical Care Toranomon
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 11 Month 26 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 11 Month 08 Day
Anticipated trial start date	2016 Year 11 Month 26 Day
Last follow-up date	2018 Year 10 Month 31 Day
Date of closure to data entry	2018 Year 10 Month 31 Day
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 25 Day
Last modified on	2018 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028496