UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between dopamine-related behavior and anhedonia in mood disorder
Acronym	Dopamine-related behavior and anhedonia
Scientific Title	Relationship between dopamine-related behavior and anhedonia in mood disorder
Scientific Title:Acronym	Dopamine-related behavior and anhedonia
Region	Japan

Condition
Condition	Mood disorder (Major depressive disorder, bipolar disorder)
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study is to investigate a relationship between dopamine-related behavior (addiction to video game and smartphone, impulsivity) and depressive symptom (anhedonia).
Basic objectives2	Others
Basic objectives -Others	none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diffeerence in total score of internet addiciton test, PHQ-9, and Sneith-Hamilton pleasure scale (SHAPS) among major depressive disorder, bipolar disorder, and healthy control.
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	- Patients with major depressive disorder or bipolar disorder according to DSM-IV-TR - Outpatients of The Jikei University Hospital or Katsushika Medical Center - Patients who can understand documents on informed consent. - Healthy volunteers who do not have a medical hitory of psychiatric disorder.
Key exclusion criteria	- Patients in manic phase - Patients who will not participate in the study according to severe psychiatric sympotoms.
Target sample size	300

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	105-8471
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	105-8471
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	2019 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	Open public recruiting
Date of protocol fixation	2019 Year 04 Month 22 Day
Date of IRB	2019 Year 06 Month 10 Day
Anticipated trial start date	2019 Year 10 Month 21 Day
Last follow-up date	2021 Year 04 Month 30 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	2019 Year 10 Month 21 Day
Last modified on	2019 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043708