UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045793 |
|---|---|
| Receipt number | R000052281 |
| Scientific Title | A Study of Depressive Symptoms and Therapeutic Decision Making in Mood Disorders |
| Date of disclosure of the study information | 2021/10/21 |
| Last modified on | 2021/10/19 16:19:59 |
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Basic information
Public title
A Study of Depressive Symptoms and Therapeutic Decision Making in Mood Disorders
Acronym
A Study of Depressive Symptoms and Therapeutic Decision Making in Mood Disorders
Scientific Title
A Study of Depressive Symptoms and Therapeutic Decision Making in Mood Disorders
Scientific Title:Acronym
A Study of Depressive Symptoms and Therapeutic Decision Making in Mood Disorders
Region
| Japan |
Condition
Condition
mood disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct an anonymous questionnaire to determine how therapeutic decision making in mood disorders is influenced by depressive symptoms.
Basic objectives2
Others
Basic objectives -Others
Therapeutic decision
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between the selection rate for Problem 1 (positive frame, see Appendix) "Treatment A" or "Treatment B" and the selection rate for Problem 2 (negative frame, see Appendix) "Treatment C" or "Treatment D" in the framing task
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. patients between 20 and 80 years old
2. outpatients or inpatients of the Department of Neuropsychiatry, The Jikei University School of Medicine, or outpatients of the Department of Neuropsychiatry, The Katsushika Medical Center, The Jikei University School of Medicine
3) Patients diagnosed with mood disorder in DSM-5
4. patients who can read and understand the cover page of the questionnaire on consent explanation
Key exclusion criteria
1. bipolar disorder patients who are in a manic state
2. patients with poor judgment due to psychiatric symptoms such as depressed mood, anxiety, agitation, elated mood, and aggression.
2) Patients with depressed mood, anxiety, agitation, elated mood, aggression, or other psychiatric symptoms that make it difficult to make decisions and voluntarily participate in research.
Patients who are judged as inappropriate by the attending physician or the physician in charge.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
kodaka@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Fumitoshi |
| Middle name | |
| Last name | Kodaka |
Organization
The Jikei University School of Medicine
Division name
Department of Psychiatry
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
kodaka@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
kodaka@jikei.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052281
