UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014676 |
|---|---|
| Receipt number | 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 | 2024/02/28 11:38:39 |
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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
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Noda |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
1-1-4 Ogawa-Higashi-Cho, Kodaira-Shi, Tokyo, 187-8551
TEL
0423412711
t-noda@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Shiori |
| Middle name | |
| Last name | Setoyama |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
1-1-4 Ogawa-Higashi-Cho, Kodaira-Shi, Tokyo, 187-8551
TEL
042-341-2711
Homepage URL
nodat_labo@ncnp.go.jp
Sponsor or person
Institute
Faculty of HumanSciences, WASEDA University
Institute
Department
Personal name
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
Institutional Review Board, National Center of Neurology and Psychiatry
Address
1-1-4 Ogawa-Higashi-Cho, Kodaira-Shi, Tokyo, 187-8551
Tel
042-341-2711
irb-office@ncnp.go.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
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
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017069
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/file/KAKENHI-PROJECT-25461790/25461790seika.pdf
Number of participants that the trial has enrolled
42
Results
Tests on healthy subjects indicated attentional function training might enhance attentional control and alleviate depression. Subsequently, ATT was applied for 7 weeks on 10 major depression patients, reducing negative rumination, anxiety, and enhancing divided attention. Depressive symptoms decreased, and "distanced attentiveness" (DM) improved. Brain function indicators revealed increased cerebral blood flow in specific regions correlated with enhanced attention control.
Results date posted
| 2024 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects were patients with major depressive disorder and healthy subjects aged 16 years and older.
The patient group was diagnosed using the Psychiatric Diagnostic Interview (SCID).
[Exclusion criteria]
Things with atypical characteristics
Those with comorbidity or history of bipolar disorder, psychotic disorder, substance-related disorder, personality disorder, or dementia
Taking tricyclic antidepressants
[Cancellation criteria]
If the patient group worsens by two or more levels on the CGI-S during the intervention period, the intervention will be discontinued.
If healthy subjects become unwell, the intervention will be discontinued at the discretion of a physician.
Participant flow
Of the 42 patients who consented to participate in the study, 16 patients in the patient group and 26 in the healthy group participated in the study. The patient group participated in an open study, and all patients were in the intervention group. The healthy subjects participated in the RCT study, with 13 patients in the intervention group and 13 patients in the control group. In the patient group, 2 patients dropped out and 4 patients had unanalyzable data, so the analysis target population was 10 patients. The analysis target population of the healthy group was 26 cases.
Adverse events
None
Outcome measures
[Biological indicators]
Cerebral blood flow test using optical topography device (NIRS)
Word fluency task (VFT) and dichotic listening task (DLT)
Magnetic resonance imaging (MRI)
3D structural images, resting brain activity, flare images, DTI, ASL
[Psychiatric symptom evaluation]
Hamilton Depression Rating Scale (HAM-D/HDS)
Young Mania Rating Scale Japanese version (YMRS-J)
Montgomery Asberg Depression Rating Scale (MADRS)
Japanese version of Beck Depression Questionnaire 2nd edition (BDI-2)
State/Trait Anxiety Test (STAI-S, T)
[Cognitive/attention function evaluation]
Attention control function measurement scale
Negative rumination scale
Japanese version of MCQ (scale to measure metacognitive beliefs)
DMMQ (scale to measure detached mindfulness)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 04 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 24 | 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 | 07 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017069
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