UMIN-CTR Clinical Trial

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	100

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	135-0063
Address	2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL	+08-3-6703-7014
Email	matsuuray@tau.ac.jp

Public contact
Name of contact person	1st name Yuto Middle name Last name Matsuura
Organization	Graduate School of Tokyo Ariake University of Medical and Health Sciences
Division name	Doctor's Program of Health Sciences
Zip code	135-0063
Address	2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL	+08-3-6703-7014
Homepage URL
Email	himorogi.hari@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	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	akiyama@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	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	Completed
Date of protocol fixation	2017 Year 03 Month 01 Day
Date of IRB	2017 Year 04 Month 19 Day
Anticipated trial start date	2017 Year 05 Month 01 Day
Last follow-up date	2022 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	2018 Year 01 Month 06 Day
Last modified on	2021 Year 11 Month 04 Day

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