UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025297 |
|---|---|
| Receipt number | 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 15:09:47 |
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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
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
sakai@tau.ac.jp
Sponsor or person
Institute
1)Tokyo Ariake University of Medical and Health Science
2)Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029089
