UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007611 |
|---|---|
| Receipt number | R000008788 |
| Scientific Title | Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2015/03/30 17:06:16 |
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Basic information
Public title
Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches
Acronym
Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches
Scientific Title
Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches
Scientific Title:Acronym
Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches
Region
| Japan |
Condition
Condition
Major depressive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate and identify a predictor of treatment response to high-frequency left prefrontal transcranial magnetic stimulation in patients with refractory depression through neurobiological, neurophysiological, and neuroimaging approaches
Basic objectives2
Others
Basic objectives -Others
To investigate and identify a predictor of treatment response to high-frequency left prefrontal transcranial magnetic stimulation in patients with refractory depression through a comprehensive approach
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HAMD 17, HAMD 24, MADRS
Severity of depression is rated with these scales every 2 weeks.
Key secondary outcomes
CGI, 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
Transcranial magnetic stimulation is administered using NeuroStar TMS Therapy System. Stimulation parameter is set at 10 Hz, 120% MT, 4 sec, 3000 pulses, and the stimulation site is the left dorsolateral prefrontal cortex.
TMS is administered for 4 weeks (fixed duration) and additionally 2-4 weeks (variable duration).
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. DSM-IV-TR diagnosis of major depressive disorder
2. Aged 20-70 y/o
3. HAMD 17 score; over 18
4. Current episode duration; 3 y
5. Insufficient clinical benefit to 1-4 adequate medication trials in the current episode
Key exclusion criteria
1. Psychotic episode, bipolar disorder, OCD, PTSD, eating disorder
2. Previous treatment with ECT, TMS, VNS, DBS, tDCS
3. Pregnancy
4. Personal or close family history of seizure disorder
5. Neurologic disorder, organic brain disease
6. Substance or alcohol dependence
7. Ferromagnetic material in body or close to head
8. Severe metabolic disease, endocrine disease
9. Active suicide idea
10. Taking medications known to lower seizure threshold
Target sample size
60
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 |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
TEL
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
杏林大学病院（東京）、国立精神・神経医療研究センター病院（東京）
Other administrative information
Date of disclosure of the study information
| 2012 | 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
| 2012 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008788
