UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the differences of voice/facial expression/behavior pattern between patients with major depressive disorder and bipolar disorder
Title of the study (Brief title)	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	Yoshinori Watanabe
Organization	Medical Corporation Jisenkai
Division name	Himorogi Psychiatric Institute
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	Yoshinori Watanabe
Organization	Medical Corporation Jisenkai
Division name	Himorogi Psychiatric Institute
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
Institute	Takeda Pharmaceutical Company Limited
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030962