UMIN-CTR Clinical Trial

Public title

The development of treatment using neurofeedback for patients with mood disorder: an exploratory study through neuroimaging approaches

Acronym

The development of treatment using neurofeedback (NFB) for patients with mood disorder

Scientific Title

The development of treatment using neurofeedback for patients with mood disorder: an exploratory study through neuroimaging approaches

Scientific Title:Acronym

The development of treatment using neurofeedback (NFB) for patients with mood disorder

Region

Japan

Condition

Mood disorders (major depressive disorder and bipolar disorder) and healthy volunteers

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to identify the changes in brain activity following NFB interventions against patients with mood disorder and to explore novel methodological approaches that effectively improve treatment effect.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Using psychological assessments and neuroimaging techniques, we evaluate psychological and neural changes in depression-related symptoms, immediately after the intervention, one week later, one month later, and again six months later.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

For depressive patients, conducting NFB training to control regional brain activities associated with major depressive disorder or to improve higher cognitive functions, such as attention and working memory, whose improvement are thought to be effective against mood disorders

Interventions/Control_2

For healthy-control individuals, establish feasibility of neurofeedback training to control regional activities associated with mood disorders. In addition, examining potentials as an alternative medicine of NFB training on cognitive functions such as attention and working memory whose improvement are thought to be effective against mood disorders.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

For patients/clients
1) Aged 20-0 years old
2) Being diagnosed as major depressive disorder or bipolar disorder (Type I, Type II) according to DSM-IV-TR or DSM-5 criteria
3) Present ongoing episode of major depressive symptoms
4) Present treatment-resistance (scores 14 points or above out of 17 items on the Hamilton Rating Scale for Depression even after >=4 weeks of treatment with sufficient amount of more than 1 anti-depressant) or low treatment-tolerance (insufficient administration due to side-effects while taking more than 1 anti-depressant)
5) Satisfactory informed consent obtained from the participant him/herself
For healthy control
1) Aged 20-80 years old
2) Not history of psychiatric disorders
3) Not having current serious medical illness
Satisfactory informed consent obtained from the participant him/herself

Key exclusion criteria

1) Decisionally impaired individuals who has diminished capacity to understand the aim of the research
2) Physically impaired individuals who are not able to complete the experiment
3) Subjects who are contraindicated for the use of MRI
Having an implanted heart pace-maker
Having implanted cerebral (arteries) clips
Having implanted neural/nerve stimulators
Having implanted pumps
Having work experience in a metal industry or possibility of metal residues remaining in the body
Having metal-tattoos (including tattooed eye-lining)
Being pregnant, or having possibility of being pregnant
4) Any individuals judged as inappropriate for the experiment by the principal investigator or a collaborating researcher

Target sample size

210

Name of lead principal investigator

1st name	Go
Middle name
Last name	Okada

Organization

Graduate school of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Psychiatry and Neurosciences

Zip code

734-8551

Address

1-2-3 Kasumi, Minamiku, Hiroshima, 734-8553, Japan

TEL

082-257-5205

Email

goookada@hiroshima-u.ac.jp

Name of contact person

1st name	Go
Middle name
Last name	Okada

Organization

Graduate school of Biomedical and Health Sciences, Hiroshima University

Division name

Department of Psychiatry and Neurosciences

Zip code

734-8551

Address

1-2-3 Kasumi, Minamiku, Hiroshima, 734-8553, Japan

TEL

082-257-5814

Homepage URL

Email

goookada@hiroshima-u.ac.jp

Institute

Department of Psychiatry and Neurosciences, Graduate school of Biomedical and Health Sciences, Hiroshima University

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee for Clinical Research of Hiroshima University

Address

1-2-3 Kasumi, Minamiku, Hiroshima

Tel

082-257-1551

Email

iryo-seisaku@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015

Year

10

Month

20

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

23

Day

Last modified on

2023

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022527