UMIN-CTR Clinical Trial

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
Email	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
Email	kodaka@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052281