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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014676
Receipt No. R000017069
Scientific Title The deficits in prefrontal cortex functions in depression and the therapeutic efficacy of the attention training technique.
Date of disclosure of the study information 2014/08/01
Last modified on 2017/07/31

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Basic information
Public title The deficits in prefrontal cortex functions in depression and the therapeutic efficacy of the attention training technique.
Acronym The deficits in prefrontal cortex functions in depression and the therapeutic efficacy of the attention training technique.
Scientific Title The deficits in prefrontal cortex functions in depression and the therapeutic efficacy of the attention training technique.
Scientific Title:Acronym The deficits in prefrontal cortex functions in depression and the therapeutic efficacy of the attention training technique.
Region
Japan

Condition
Condition Major depressive disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The first aim of this study is to confirm the effect of ATT on alleviating depression symptoms, including rumination, and its effectiveness on preventing the recurrence of depression. The second aim is to reveal the functional deficits of the prefrontal cortex in depression, and to verify how much that could be improved by practicing ATT.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Hamilton Rating Scale for Depression
Beck Depression Inventory
Montgomery-Asberg Depression Rating Scale
Meta-cognitions Questionnaire-30
Detached Mindfulness Mode Questionnaire
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention of the ATT( attention training technique) is usually performed for 8 weeks in treatment.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who were diagnosed as major depression disorder using the Structured Clinical Interviews for DSM-5(SCID-1).
Key exclusion criteria Atypical features, bipolar disorders, psychotic disorders, substance-related disorders, personality disorders, comorbid with or having any history of dementia, dosing tricyclic antidepressant drugs
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takamasa Noda
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Department of Psychiatry
Zip code
Address 1-1-4 Ogawa-Higashi-Cho, Kodaira-Shi, Tokyo, 187-8551
TEL 042-341-2711
Email t-noda@ncnp.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shiori Setoyama, Kyoko Murakami
Organization National Center Hospital, National Center of Neurology and Psychiatry
Division name Near-Infrared Spectroscopy laboratory
Zip code
Address 1-1-4 Ogawa-Higashi-Cho, Kodaira-Shi, Tokyo, 187-8551
TEL 042-341-2711
Homepage URL
Email nodat_labo@ncnp.go.jp

Sponsor
Institute Faculty of HumanSciences, WASEDA University
Institute
Department

Funding Source
Organization Intramural Research Grant for Neurological and Psychiatric Disorders of NCNP
Organization
Division
Category of Funding Organization Other
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 国立研究開発法人国立精神・神経医療研究センター病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 08 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 Enrolling by invitation
Date of protocol fixation
2014 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 12 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
2014 Year 07 Month 28 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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