UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007611
Receipt number R000008788
Scientific Title Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches
Date of disclosure of the study information 2012/04/01
Last modified on 2015/03/30 17:06:16

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Basic information

Public title

Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches

Acronym

Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches

Scientific Title

Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches

Scientific Title:Acronym

Treatment of refractory depression using NeuroStar TMS Therapy System and a predictor of the treatment response: a comprehensive, exploratory study through neurobiological, neurophysiological, and neuroimaging approaches

Region

Japan


Condition

Condition

Major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate and identify a predictor of treatment response to high-frequency left prefrontal transcranial magnetic stimulation in patients with refractory depression through neurobiological, neurophysiological, and neuroimaging approaches

Basic objectives2

Others

Basic objectives -Others

To investigate and identify a predictor of treatment response to high-frequency left prefrontal transcranial magnetic stimulation in patients with refractory depression through a comprehensive approach

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

HAMD 17, HAMD 24, MADRS
Severity of depression is rated with these scales every 2 weeks.

Key secondary outcomes

CGI, YMRS


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Transcranial magnetic stimulation is administered using NeuroStar TMS Therapy System. Stimulation parameter is set at 10 Hz, 120% MT, 4 sec, 3000 pulses, and the stimulation site is the left dorsolateral prefrontal cortex.
TMS is administered for 4 weeks (fixed duration) and additionally 2-4 weeks (variable duration).

Interventions/Control_2


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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

1. DSM-IV-TR diagnosis of major depressive disorder
2. Aged 20-70 y/o
3. HAMD 17 score; over 18
4. Current episode duration; 3 y
5. Insufficient clinical benefit to 1-4 adequate medication trials in the current episode

Key exclusion criteria

1. Psychotic episode, bipolar disorder, OCD, PTSD, eating disorder
2. Previous treatment with ECT, TMS, VNS, DBS, tDCS
3. Pregnancy
4. Personal or close family history of seizure disorder
5. Neurologic disorder, organic brain disease
6. Substance or alcohol dependence
7. Ferromagnetic material in body or close to head
8. Severe metabolic disease, endocrine disease
9. Active suicide idea
10. Taking medications known to lower seizure threshold

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinsuke Kito

Organization

Kyorin University School of Medicine

Division name

Department of Neuropsychiatry

Zip code


Address

6-20-2 Shinkawa, Mitaka, Tokyo 181-8611, Japan

TEL

0422-47-5511

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kyorin University School of Medicine

Division name

Department of Neuropsychiatry

Zip code


Address


TEL


Homepage URL


Email

psychiat@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Department of Neuropsychiatry, Kyorin University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

杏林大学病院(東京)、国立精神・神経医療研究センター病院(東京)


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 01 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

2012 Year 03 Month 26 Day

Date of IRB


Anticipated trial start date

2012 Year 04 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 03 Month 30 Day

Last modified on

2015 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name