UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016405
Receipt number R000019033
Scientific Title Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression
Date of disclosure of the study information 2015/02/02
Last modified on 2019/08/08 17:13:14

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Basic information

Public title

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression

Acronym

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression

Scientific Title

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression

Scientific Title:Acronym

Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and predictors of treatment response in major depression

Region

Japan


Condition

Condition

Major depressive disorder and bipolar disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the mechanism of recovery from depression following rTMS and the potential predictors of treatment response

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Near Infrared Spectroscopy (NIRS), 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

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Left dorsolateral prefrontal cortex high-frequency rTMS, or, right dorsolateral prefrontal cortex low-frequency rTMS

Interventions/Control_2

Patients without rTMS

Interventions/Control_3

Healthy volunteers without rTMS

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who are diagnosed as major depressive disorder or bipolar disorder according to SCID, and healthy volunteers without psychiatric disorders

Key exclusion criteria

Subjects who are contraindicated for the use of MRI
Subjects do not have capability of informed consent
Subjects who are judged as unsuitable for participation in this study
Concerning the patients with rTMS, patients who are contraindicated for rTMS are excluded.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Toshiyuki
Middle name
Last name Yamashita

Organization

Kyoto Prefectural Rakunan Hospital

Division name

Department of Psychiatry

Zip code

611-0011

Address

2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan

TEL

0774-32-5900

Email

rakunanhp-shomu@pref.kyoto.lg.jp


Public contact

Name of contact person

1st name Nobuyuki
Middle name
Last name Yamasaki

Organization

Kyoto Prefectural Rakunan Hospital

Division name

Department of Psychiatry

Zip code

611-0011

Address

2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan

TEL

0774-32-5900

Homepage URL


Email

rakunanhp-shomu@pref.kyoto.lg.jp


Sponsor or person

Institute

Kyoto Prefectural Rakunan Hospital

Institute

Department

Personal name



Funding Source

Organization

Kyoto prefecture

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Rakunan Hospital Ethics Committee

Address

2, Hirookadani, Gokasho, Uji City, Kyoto 611-0011, Japan

Tel

0774-32-5900

Email

rakunanhp-shomu@pref.kyoto.lg.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

洛南病院(京都府)


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 02 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

81

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

2013 Year 09 Month 02 Day

Date of IRB

2013 Year 10 Month 01 Day

Anticipated trial start date

2013 Year 11 Month 06 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

This study was approved by the Ethics Committee at Kyoto Prefectural Rakunan Hospital under the title of "Effectiveness of repetitive transcranial magnetic stimulation (rTMS) and neural responses following rTMS in major depression". The data partially overlap with the data in the study entitled "Neural responses following transcranial magnetic stimulation (rTMS) in major depression (UMIN000013493)"


Management information

Registered date

2015 Year 01 Month 31 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=R000019033


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name