UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002437 |
|---|---|
| Receipt number | R000002981 |
| Scientific Title | Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation. |
| Date of disclosure of the study information | 2009/09/03 |
| Last modified on | 2013/09/26 12:13:36 |
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Basic information
Public title
Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Acronym
Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Scientific Title
Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Scientific Title:Acronym
Prefrontal reactivity in mood disorders during repetitive transcranial magnetic stimulation.
Region
| Japan |
Condition
Condition
major depressive disorder,
bipolar disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reactivity in the left dorsolateral prefrontal cortex during and immediately after active and sham rTMS at low-frequency (1Hz) over the right prefrontal cortex.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
To monitor the regional cerebral blood volume changes using multichannel near-infrared spectroscopy.
Key secondary outcomes
Clinical symptoms of the patients were evaluated using the 24-item Hamilton Rating Scale for Depression, and the level of social functioning of all the subjects were assessed using the Global Assessment of Functioning scores.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
The low frequency repetitive transcranial magnetic stimulation to the right prefrontal cortex.
Interventions/Control_2
sham stimulation.
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
| 27 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with MDD and BD were diagnosed in accordance with the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th ed.
Key exclusion criteria
The exclusion criteria was strictly followed the report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation by Wassermann.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MAsato Fukuda |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8188
yaoyama@med.gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Aoyama |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Psychiatry and Neuroscience
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8188
Homepage URL
yaoyama@med.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
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
群馬大学医学部附属病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 03 | 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
| 2004 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 03 | Day |
Last modified on
| 2013 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002981
