UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027139
Receipt number R000030962
Scientific Title Study on the differences of voice/facial expression/behavior pattern between patients with major depressive disorder and bipolar disorder
Date of disclosure of the study information 2017/04/27
Last modified on 2017/04/25 10:12:37

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Basic information

Public title

Study on the differences of voice/facial expression/behavior pattern between patients with major depressive disorder and bipolar disorder

Acronym

Distinguish between patients with major depressive disorder and those with bipolar disorder

Scientific Title

Study on the differences of voice/facial expression/behavior pattern between patients with major depressive disorder and bipolar disorder

Scientific Title:Acronym

Distinguish between patients with major depressive disorder and those with bipolar disorder

Region

Japan


Condition

Condition

Major depressive disorder (MDD)
Bipolar disorder (BP)

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the possibility of distinguishing differences between MDD and BP episodes through voices, facial expressions, and behavior patterns.

Basic objectives2

Others

Basic objectives -Others

To investigate the association between cognitive functions and voice/facial expression/behavior pattern in patients with MDD and BP.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare the scores of Montgomery-Asberg Depression Rating Scale (MADRS) and the data of voice/facial expression/behavior pattern.

Key secondary outcomes

Compare the scores of multiple measures (YMRS, HSDS/HSAS, DSST, PDQ-5) and the data of voice/facial expression/behavior pattern.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria are included in this study:
1) Those treated as an outpatient or healthy adults.
2) Those aged between 20 and 75 at the time of signing the informed consent.
3) Those who have been diagnosed or newly diagnosed with MDD or BP as defined by DSM-5 criteria (excluding unipolar manic episodes), or healthy adults.
4) Those deemed to be able to understand and comply with the protocol details according to the decision of the principal investigator.
5) Those who can sign and date the written informed consent prior to the initiation of any of the study procedures.

Key exclusion criteria

Patients who meet any of the following criteria are excluded from this study:
1) Those with complications or past history of any of the following psychiatric disorders and/or neurological disorders:
-Those with any psychiatric disorders other than MDD or BP (as defined by DSM-5).
-Those with MDD, BP, or schizophrenia accompanied by psychotic features, or with complications or history of other psychotic disorders (including substance-related mental disorders, or mental disorders caused by general physical diseases) as defined by DSM-5.
2) Those who are at significant risk of suicide.
3) Those who have a history of severe allergy or hypersensitivity to drugs.
4) Those who are pregnant or lactating or have pregnancy wishes when obtaining the informed consent.
5) Those who are unsuitable for this study for any other reasons according to decisions by the principal investigator or other investigators.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Watanabe

Organization

Medical Corporation Jisenkai

Division name

Himorogi Psychiatric Institute

Zip code


Address

Ichigaya-Asukara Bldg. 1F2F, 2-31-3 Ichigayatamachi, Shinjuku-ku, Tokyo 162-0843, Japan

TEL

03-5946-8586

Email

watanabe@himorogi.org


Public contact

Name of contact person

1st name
Middle name
Last name Yoshinori Watanabe

Organization

Medical Corporation Jisenkai

Division name

Himorogi Psychiatric Institute

Zip code


Address

Ichigaya-Asukara Bldg. 1F2F, 2-31-3 Ichigayatamachi, Shinjuku-ku, Tokyo 162-0843, Japan

TEL

03-5946-8586

Homepage URL


Email

watanabe@himorogi.org


Sponsor or person

Institute

Takeda Pharmaceutical Company Limited

Institute

Department

Personal name



Funding Source

Organization

Takeda Pharmaceutical Company Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 27 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

Preinitiation

Date of protocol fixation

2017 Year 03 Month 29 Day

Date of IRB


Anticipated trial start date

2017 Year 05 Month 15 Day

Last follow-up date

2019 Year 05 Month 15 Day

Date of closure to data entry

2019 Year 06 Month 15 Day

Date trial data considered complete

2019 Year 11 Month 15 Day

Date analysis concluded

2020 Year 11 Month 15 Day


Other

Other related information

<Observation Period>
MDD: 8 weeks
BP: 8 weeks (up to 1 year until manic episodes appear)
Healthy adults: 8 weeks


Management information

Registered date

2017 Year 04 Month 26 Day

Last modified on

2017 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030962


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name