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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024998
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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