UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004277 |
|---|---|
| Receipt number | R000004658 |
| Scientific Title | Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial |
| Date of disclosure of the study information | 2010/10/01 |
| Last modified on | 2012/10/11 19:12:40 |
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Basic information
Public title
Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Acronym
Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Scientific Title
Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Scientific Title:Acronym
Theta-burst transcranial magnetic stimulation in the treatment of depression: A double-blind, randomized, placebo-controlled crossover trial
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate 1) the efficacy of intermittent theta-burst stimulation (iTBS) and continuous theta-burst stimulation (cTBS) over the prefrontal cortex in depression, 2) changes in biological markers associated with depression before and after theta-burst stimulation, and 3) changes in electroencephalography and polysomnography before and after theta-burst stimulation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HAMD, MADRS, and CGI at baseline, week 1, week 2, week 3, and week 4
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
iTBS or cTBS will be applied in the left and right prefrontal cortex.
Sham (1 week), Washout (3 weeks), Left TBS (1 week), Washout (3 weeks), Right TBS (1 week)
Interventions/Control_2
Left TBS (1 week), Washout (3 weeks), Right TBS (1 week), Washout (3 weeks), Sham (1 week)
Interventions/Control_3
Right TBS (1 week), Washout (3 weeks), Sham (1 week), Washout (3 weeks), Left TBS (1 week)
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with DSM-IV-TR of major depressive disorder
2)Patients scored greater than 18 on the HAMD
3)Patients have failed a minimum of 1 course of antidepressant medication in the current depressive episode
Key exclusion criteria
1)Severe suicidal idea
2)Neurological disorders/organic brain disorders
3)History of convulsive disorders
4)Drug or alcohol abuse/dependence
5)Implanted electronic devices/magnetic material
6)Severe physical diseases
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kito |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan
TEL
0422-47-5511
Homepage URL
psychiat@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
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
杏林大学付属病院（東京）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 09 | Month | 28 | Day |
Last modified on
| 2012 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004658
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
