UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013493 |
|---|---|
| Receipt number | R000015747 |
| Scientific Title | Neural responses following transcranial magnetic stimulation (rTMS) in major depression |
| Date of disclosure of the study information | 2014/03/25 |
| Last modified on | 2019/08/08 12:42:15 |
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Basic information
Public title
Neural responses following transcranial magnetic stimulation (rTMS) in major depression
Acronym
Neural responses following transcranial magnetic stimulation (rTMS) in major depression
Scientific Title
Neural responses following transcranial magnetic stimulation (rTMS) in major depression
Scientific Title:Acronym
Neural responses following transcranial magnetic stimulation (rTMS) in major depression
Region
| Japan |
Condition
Condition
Patients (Major depressive disorder and bipolar II disorder) and healthy controls
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the neural mechanism of recovery from depression following rTMS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluate neural responses following rTMS using multi-modality of MRI and psychological tests.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Navigation-guided high-frequency rTMS
site: left dorsolateral prefrontal cortex
frequency: 10Hz (4sec. train, 26sec. interval)
intensity: 100-120% resting motor threshold (RMT)
number of pulses: 2000-3000 pulses/session
number of sessions: 20-30 sessions
Interventions/Control_2
Healthy controls do not receive rTMS.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients
1. Aged 20-75 years-old, male and female
2. Diagnosis of major depressive disorder or bipolar II disorder
3. Current diagnosis of major depressive episode
4. HAMD_17 >=14 or BDI >=20
5. resistent to medication (including medication intolerance)
6. Capability of informed consent
Healthy controls
1. Aged 20-75 years-old, male and female without psychiatric disorder
2. No family history of major depressive disorder and bipolar disorder in their first relatives
3. Capability of informed consent
Key exclusion criteria
Patients and healthy controls
1. Implanted cardiac pacemaker
2. Surgical aneurysm clips
3. Neurostimulator
4. Implanted pumps
5. Metal fragments in body
6. Subjects who are contraindicated for the use of MRI [e.g. Tattoos, permanent eyeliner (if ink contains metallic specks)]
7. Diagnosis of neurological disorders (including epilepsy), substance dependence, or current serious medical illness (e.g. severe cardiac disease)
8. History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
9. Subjects with pregnancy or during lactation.
10. Subjects who are judged as unsuitable for participation in this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Murai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Psychiatry
Zip code
606-8507
Address
Shogoin-Kawaharacho54, Kyoto 606-8507, Japan
TEL
075-751-4947
Murai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Murai |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Psychiatry
Zip code
606-8507
Address
Shogoin-Kawaharacho54, Kyoto 606-8507, Japan
TEL
075-751-4947
Homepage URL
Murai@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
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
Other related organizations
Co-sponsor
Rakunan hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Certified Review Board
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学附属病院、京都府立洛南病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 25 | 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
43
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
| 2014 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015747
