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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007611
Receipt No. 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

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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
Email

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
Email psychiat@ks.kyorin-u.ac.jp

Sponsor
Institute Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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