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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027139
Receipt No. 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

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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
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)

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
URL(English) 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


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