UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007794 |
|---|---|
| Receipt number | R000009167 |
| Scientific Title | A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, followed by a semi-crossover open trial of rTMS. |
| Date of disclosure of the study information | 2012/04/23 |
| Last modified on | 2020/04/27 12:03:20 |
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Basic information
Public title
A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, followed by a semi-crossover open trial of rTMS.
Acronym
A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder.
Scientific Title
A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder, followed by a semi-crossover open trial of rTMS.
Scientific Title:Acronym
A sham-controlled, double-blind, parallel-group, randomized trial of repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder.
Region
| Japan |
Condition
Condition
Major depressive disorder (Monopolar depression)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
A main purpose of this clinical trial is to evaluate safety and efficacy, including antidepressant effect and prefrontal cognitive enhancement, of rTMS applied to medication-resistant major depression, compared with sham-control group. Moreover, rTMS-induced alterations are longitudinally investigated using MRI, EEG, and heart rate variability (vagal function). Furthermore, two different protocols of rTMS (high and low frequency rTMS) are compared in terms of safety, efficacy, and neurobiological changes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
1) Hamilton Depression Rating Scale (Ham-D) 17items and 24items: weekly evaluation
2) rTMS side effects questionnaire, which was translated in Japanese from original version of Center for Noninvasive Brain Stimulation, Harvard Medical School.: evaluated every rTMS session
Key secondary outcomes
3) Beck Depression Inventry II (BDI-II): weekly evaluation
4) State-Trait Anxiety Inventory (STAI): weekly evaluation
5) Neuropsychological Testings (Verbal Fluency Test; VFT, Wisconsin Card Sorting Test; WCST, Color Stroop Test; CST, Trail Making Test; TMT): biweekly evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Navigation-guided high-frequency rTMS
TMS coil: air-cooled figure-of-eight coil
site: left dorsolateral prefrontal cortex (lt.DLPFC)
frequency: 10Hz (4sec. train, 26sec. interval)
intensity: 100% resting motor threshold (RMT)
number of pulses: 2000pulses/session
time of session: 25 minutes
number of sessions: 20 to 30 sessions (4 to 6 weeks)
others: concomitant application of electric pulses over left forehead synchronized with TMS pulses for high-quality sham condition
Interventions/Control_2
Navigation-guided low-frequency rTMS
TMS coil: air-cooled figure-of-eight coil
site: right dorsolateral prefrontal cortex (rt.DLPFC)
frequency: 1Hz
intensity: 100% resting motor threshold (RMT)
number of pulses: 2000pulses/session
time of session: 33 minutes
number of sessions: 20 to 30 sessions (4 to 6 weeks)
others: concomitant application of electric pulses over right forehead synchronized with TMS pulses for high-quality sham condition
Interventions/Control_3
Navigation-guided high-frequency sham rTMS
TMS coil: air-cooled sham coil (figure-of-eight)
site: left dorsolateral prefrontal cortex (lt.DLPFC)
frequency: 10Hz (4sec. train, 26sec. interval)
intensity: 60% maximum machine output
number of pulses: 2000pulses/session
time of session: 25 minutes
number of sessions: 20 to 30 sessions (4 to 6 weeks)
others: concomitant application of electric pulses over left forehead synchronized with TMS pulses for high-quality sham condition
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Aged 20-75 years-old, male and female, inpatients, self-sustained ADL
2. Capability of informed consent
3. DSM-IV-TR diagnosis of major depressive disorder, single episode (296.2x) or recurrent (296.3x)
4. Current episode duration: more than 8 weeks and less than 5 years
5. Hamilton Scale for Depression 17-item score: more than 14
6. Medication resistance (insufficient clinical benefit to more than 2 medication trials) or medication intolerance (intolerant to more than 2 medication trials) during current episode
Key exclusion criteria
1. Absolute contraindications of rTMS (inplanted medical devices or intracranial ferromagnetic material)
2. Relative contraindications of rTMS, including a) pregnancy, b) seizure disorders or paroxysmal EEG abnormality, and c) medications known to lower seizure threshold
3. Other current Axis I disorders
4. Suicidality (Ham-D suicidality score more than 3)
5. Psychotic features during current episode
6. Instability of physical conditions
7. History of neurologic disorders
8. Previous treatments with rTMS and VNS, and treatment history of ECT within a year
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Motoaki |
| Middle name | |
| Last name | Nakamura |
Organization
Kinkou Hospital, Kanagawa Psychiatric Center
Division name
Laboratory of Neuromodulation
Zip code
233-0006
Address
2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan
TEL
045-822-0241
motoaki@motoaki.com
Public contact
Name of contact person
| 1st name | Motoaki |
| Middle name | |
| Last name | Nakamura |
Organization
Kinkou Hospital, Kanagawa Psychiatric Center
Division name
Laboratory of Neuromodulation
Zip code
233-0006
Address
2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan
TEL
045-822-0241
Homepage URL
http://www.kinkou.org/rTMS.html
motoaki@motoaki.com
Sponsor or person
Institute
Kinkou Hospital, Kanagawa Psychiatric Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Kanagawa Psychiatric Center
Address
2-5-1, Serigaya, Kounan-ku, Yokohama, Kanagawa, Japan
Tel
045-822-0241
asai.20031@kanagawa-pho.jp
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
| 2012 | Year | 04 | Month | 23 | 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
| 2011 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2011 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 20 | Day |
Last modified on
| 2020 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009167
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| Registered date | File name |
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