UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013493
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email Murai@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.