UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024752 |
|---|---|
| Receipt number | R000028446 |
| Scientific Title | Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2017/05/09 17:24:55 |
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Basic information
Public title
Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders
Acronym
Effect of repetitive transcranial magnetic stimulation (rTMS)
Scientific Title
Effect of repetitive transcranial magnetic stimulation (rTMS) on brain morphology and function in refractory mental disorders
Scientific Title:Acronym
Effect of repetitive transcranial magnetic stimulation (rTMS)
Region
| Japan |
Condition
Condition
patients with depressive state who meet criteria for mood disorders or schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of rTMS (real or sham stimulation) on brain morphology and function in patients with depressive state who meet criteria of mood disorders or schizophrenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Hamilton Rating Scale for Depression
Key secondary outcomes
Beck Depression Inventory
Brief Assesment of Cognition in Schizophrenia-Japanese version(BACS-J)
brain MRI
brain SPECT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
1)real rTMS (20Hz), 2000 pulses per session
2)five treatment sessions per week during a period of four to six weeks
Interventions/Control_2
1)sham rTMS
2)five treatment sessions per week during a period of four to six 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patient with depressive state, who meets ICD-10 criteria for mood disorders or schizophrenia
2)non responder to medication for over half a year
3)20 years of age or over
4)gave written informed consent
Key exclusion criteria
1)past history of seizure
2)intracerebral metal
3)dependence on alcohol
4)serious cardiac disorder
5)cochlea implant
6)artificial cardiac pacemaker
7)infusion pump
8)any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Higuchi |
Organization
University of Toyama
Division name
Department of Neuropsychiatry
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7323
yhiguchi@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Higuchi |
Organization
University of Toyama
Division name
Department of Neuropsychiatry
Zip code
Address
2630 Sugitani, Toyama
TEL
076-434-7323
Homepage URL
yhiguchi@med.u-toyama.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Neuropsychiatry, University of Toyama Graduate School of Medicine and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
N/A
Name of secondary funder(s)
N/A
IRB Contact (For public release)
Organization
Address
Tel
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
富山大学附属病院／Toyama University Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 08 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028446
