UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013553 |
|---|---|
| Receipt number | R000014416 |
| Scientific Title | The feasibility study of transcranial magnetic stimulation for resistant major depressive episode |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2018/06/18 11:19:51 |
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Basic information
Public title
The feasibility study of transcranial magnetic stimulation for resistant major depressive episode
Acronym
The feasibility study of transcranial magnetic stimulation for resistant major depressive episode
Scientific Title
The feasibility study of transcranial magnetic stimulation for resistant major depressive episode
Scientific Title:Acronym
The feasibility study of transcranial magnetic stimulation for resistant major depressive episode
Region
| Japan |
Condition
Condition
major depressive disorder,
bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and preliminary efficacy of transcranial magnetic stimulation for resistant major depressive episode
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Adherence to treatment
Key secondary outcomes
1)Beck Depression Inventry II(BDI-II)
2)Hamilton Depression Rating Scale (Ham-D) 17items
3)Montgomery Asberg Depression Scale (MADRS)
4)Frequency,Intensity, and Burden of Side Effects Rating (FIBSER)
5)Young Manic Rating Scale (YMRS)
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
Low-frequency rTMS to the right dorsolateral prefrontal cortex
or
High-frequency rTMS to the left dorsolateral prefrontal cortex
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)DSM-IV-TR diagnosis of major depressive disorder (MDD) or bipolar disorder (BD)
2)Hamilton Scale for Depression 17-item score: 14 or more
3)Medication resistance(Insufficient clinical improvement of MDD from at least two antidepressant trials/ Insufficient clinical improvement of BD from lithium or lamotrigine and atypical antipsychotic treatment )
4)Capability of informed consent
5)Aged 20 years old or more
Key exclusion criteria
1)Other Axis I disorders
2)Axis II disorders
3)Seizure-inducing disease (brain tumor, head injury, etc.)
4)Neurologic disorder, organic brain disorder
5)History of seizure
6)Paroxysmal EEG abnormality
7)Pregnancy
8)Ferromagnetic material in head(except oral cavity)
9)Patients with a pacemaker
10)Active suicide idea
11)Stupor state
12)Previous treatment with electroconvulsive therapy within one month
13)Depressive patients related to physical diseases or drugs
14)Family members of researchers
15)Patients likely to change to another hospital within 6 months
16)Patients judged to be not appropriate for participation in this study by the physician
17) Patients who do not understand Japanese
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seishi Terada |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Neuropsychiatry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7246
terada@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Inagaki |
Organization
Okayama University Hospital
Division name
Department of Neuropsychiatry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL
086-235-7246
Homepage URL
masatoshiinagaki@med.okayama-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Science
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okayama Psychiatric Medical Center
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
| 2014 | Year | 03 | Month | 28 | Day |
Last modified on
| 2018 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014416
