UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024998
Receipt number R000028496
Scientific Title Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial
Date of disclosure of the study information 2016/11/26
Last modified on 2018/05/28 09:36:07

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Basic information

Public title

Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial

Acronym

Efficacy and safety of dTMS in treatment-resistant MDD and BD

Scientific Title

Efficacy and safety of deep transcranial magnetic stimulation in treatment-resistant major depressive disorder and bipolar disorder: a randomized, double-blind, sham-controlled trial

Scientific Title:Acronym

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

1st name
Middle name
Last name Shinsuke Kito

Organization

National Center Hospital, National Center of Neurology and Psychiatry

Division name

Department of Psychiatry and Advanced Medical Technology

Zip code


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

1st name
Middle name
Last name Toshihide Hayashi

Organization

Medical Care Toranomon

Division name

Medical Care Toranomon

Zip code


Address

1-16-16 Toranomon, Minatoku, Tokyo 105-0001, Japan

TEL

03-5510-3898

Homepage URL


Email

dtms@medcare-tora.com


Sponsor or person

Institute

Medical Care Toranomon

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

No longer recruiting

Date of protocol fixation

2016 Year 11 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name