UMIN-CTR Clinical Trial

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
Last 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
1st 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