UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000015747