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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030714
Receipt No. R000035065
Scientific Title Effect of acupuncture on major depressive disorder and bipolar disorder
Date of disclosure of the study information 2018/01/06
Last modified on 2018/01/06

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Basic information
Public title Effect of acupuncture on major depressive disorder and bipolar disorder
Acronym Effect of acupuncture on major depressive disorder and bipolar disorder
Scientific Title Effect of acupuncture on major depressive disorder and bipolar disorder
Scientific Title:Acronym Effect of acupuncture on major depressive disorder and bipolar disorder
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is to examine the effect of acupuncture treatment on depression and bipolar disorder.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Himorogi self-rating depression scale
Key secondary outcomes Himorogi self-rating anxiety scale
Somatic Symptom Scale-8
Visual Analogue Scale
SF8 Health Survey
Salivary cortisol

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Those aged 18 or over with MDD(by DSM-5)
2.Those aged 18 or over with BD(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).
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakai Tomomi
Organization Tokyo Ariake University of Medical and Health Science
Division name Department of Acupuncture and Moxibustion
Zip code
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
Middle name
Last name Matsuura Yuto
Organization Graduate School of Tokyo Ariake University of Medical and Health Sciences
Division name Doctor's Program of Health Sciences
Zip code
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL +08-3-6703-7000
Homepage URL
Email matsuyuto0210@gmail.com

Sponsor
Institute Tokyo Ariake University of Medical and Health Science
Institute
Department

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

Other related organizations
Co-sponsor Himorogi Psychiatric Institute
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 市ヶ谷ひもろぎクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 06 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 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
2018 Year 01 Month 06 Day
Last modified on
2018 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035065

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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