UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053763 |
|---|---|
| Receipt number | R000061356 |
| Scientific Title | Association between light exposure and Schizophrenia |
| Date of disclosure of the study information | 2024/03/03 |
| Last modified on | 2024/03/03 17:01:47 |
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Basic information
Public title
Association between light exposure and Schizophrenia
Acronym
Association between light exposure and Schizophrenia
Scientific Title
Association between light exposure and Schizophrenia
Scientific Title:Acronym
Association between light exposure and Schizophrenia
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to measure the daytime and nighttime light exposure of individuals with schizophrenia using a photmeter, and to elucidate whether the light exposure environment in daily life is associated with symptoms, including circadian rhythm, sleep, mood, and obesity, in schizophrenia.
Basic objectives2
Others
Basic objectives -Others
The aim is to measure the daytime and nighttime light exposure of individuals with schizophrenia using a photmeter, and to elucidate whether the light exposure environment in daily life is associated with symptoms, including circadian rhythm, sleep, mood, and obesity, in schizophrenia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between light exposure in daily life and circadian rhythm
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A diagnosis of Schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders (fifth edition)
Key exclusion criteria
Night shift workers and those judged by a clinician to be at serious suicidal risk were excluded.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Esaki |
Organization
Fujita Health University
Division name
Psychiatry
Zip code
4701192
Address
Toyoake, Aichi 4701192, Japan
TEL
+81-562-93-9250
esakiz@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Esaki |
Organization
Fujita Health University
Division name
Psychiatry
Zip code
4701192
Address
Toyoake, Aichi 4701192, Japan
TEL
+81-562-93-9250
Homepage URL
esakiz@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from JSPS KAKENHI
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
Okehazama Hospital
Address
Aichi, Toyoake
Tel
0562-97-1361
esakiz@fujita-hu.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
| 2024 | Year | 03 | Month | 03 | 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
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2024 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061356
