UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038352 |
|---|---|
| Receipt number | R000043708 |
| Scientific Title | Relationship between dopamine-related behavior and anhedonia in mood disorder |
| Date of disclosure of the study information | 2019/10/21 |
| Last modified on | 2019/10/21 16:58:37 |
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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
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043708
