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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025297
Receipt No. R000029089
Scientific Title Effect of acupuncture on cerebral blood flow in patients with major depressive disorder - Evaluation using arterial spin-labeled magnetic resonance imaging -
Date of disclosure of the study information 2016/12/16
Last modified on 2019/05/16

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Basic information
Public title Effect of acupuncture on cerebral blood flow in patients with major depressive disorder - Evaluation using arterial spin-labeled magnetic resonance imaging -
Acronym Effect of acupuncture on cerebral blood flow in patients with major depressive disorder - Evaluation using arterial spin-labeled magnetic resonance imaging -
Scientific Title Effect of acupuncture on cerebral blood flow in patients with major depressive disorder - Evaluation using arterial spin-labeled magnetic resonance imaging -
Scientific Title:Acronym Effect of acupuncture on cerebral blood flow in patients with major depressive disorder - Evaluation using arterial spin-labeled magnetic resonance imaging -
Region
Japan

Condition
Condition Major Depressive Disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 One of the pathologies of depression is the reduction of cerebral blood flow centered on the prefrontal cortex. Especially, it is reported that the dorsal prefrontal cortex changes the blood flow dynamics to the mood state dependence, and the blood flow which has decreased is improved as the symptoms improve. It is suggested that the mechanism of acupuncture may influence not only the local reaction but also the high-level central nervous system. Acupuncture treatment for depression may also influence the high-level central nervous system, possibly improving symptoms. However, there are few studies on the mechanism of acupuncture for depression. Therefore, in this study, using the Arterial spin-labeled MRI which is noninvasive and iterative examination, it compares changes in cerebral blood flow rate before and after acupuncture stimulation and clarifies a part of the mechanism of acupuncture effect on depression.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes cerebral blood flow
Key secondary outcomes Hamilton Depression Rating Scale(HAMD)

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
Maneuver
Interventions/Control_1 Acupuncture
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Those aged 18 or over with MDD(by DSM-5)
Key exclusion criteria 1)Those with convulsive disorders such as schizoph.
2)Those with depression or depressive state caused by organic brain damages.
3)Those with severe disorders in liver, kidney, blood or circulation.
4)Those with malignancy or its previous history.
5)Those pregnant, nursing, or who may become pregnant.
6)Those with heavy suicidal tendency, previous history of suicidal ideation, or suicide attempt.
7)Those with personality disorder, mental retardation or intractable depression at a physician's discretion.
8)Those with substance dependence or drug abuse (excluding disorders related to nicotine).
9)Those with experience of causing claustrophobic reaction.
10)Those with wearing a cardiac pacemaker or holding a prosthetic heart valve.
11)Subjects who possesses metals in the body that cannot be confirmed as nonmagnetic (tattoo etc.).
12)Subjects who poor body temperature control.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Sakai
Organization Tokyo Ariake University of Medical and Health Science
Division name Department of Acupuncture and Moxibustion
Zip code 351-0115
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL +08-3-6703-7000
Email sakai@tau.ac.jp

Public contact
Name of contact person
1st name Tomomi
Middle name
Last name Sakai
Organization Tokyo Ariake University of Medical and Health Science
Division name Department of Acupuncture and Moxibustion
Zip code 351-0115
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL +08-3-6703-7000
Homepage URL
Email sakai@tau.ac.jp

Sponsor
Institute 1)Tokyo Ariake University of Medical and Health Science
2)Saitama Medical University
Institute
Department

Funding Source
Organization Tokyo Ariake University of Medical and Health Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Ariake University of Medical and Health Science
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel +08-3-6703-7000
Email kida@tau.ac.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 埼玉医科大学総合医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 16 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
2016 Year 11 Month 22 Day
Date of IRB
2017 Year 05 Month 11 Day
Anticipated trial start date
2018 Year 02 Month 17 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 16 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029089

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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