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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
