UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058727 |
|---|---|
| Receipt number | R000067061 |
| Scientific Title | Longitudinal associations between serum orexin A levels and physical activity, sleep, and clinical indicators in patients with schizophrenia: an exploratory study |
| Date of disclosure of the study information | 2025/08/07 |
| Last modified on | 2025/08/07 15:58:47 |
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Basic information
Public title
Longitudinal associations between serum orexin A levels and physical activity, sleep, and clinical indicators in patients with schizophrenia: an exploratory study
Acronym
Longitudinal associations between serum orexin A levels and physical activity, sleep, and clinical indicators in patients with schizophrenia: an exploratory study
Scientific Title
Longitudinal associations between serum orexin A levels and physical activity, sleep, and clinical indicators in patients with schizophrenia: an exploratory study
Scientific Title:Acronym
Longitudinal associations between serum orexin A levels and physical activity, sleep, and clinical indicators in patients with schizophrenia: an exploratory study
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to explore the longitudinal associations between serum orexin-A levels and physical activity, sleep, and clinical symptoms in patients with chronic schizophrenia, in order to investigate the potential pathophysiological role of orexin-A.
Basic objectives2
Others
Basic objectives -Others
Exploratory retrospective study on pathophysiology and biomarker discovery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between changes in serum orexin A concentration and changes in physical activity
Key secondary outcomes
Relationship between changes in serum orexin A concentration and changes in sleep and clinical indices
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
| Not applicable |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Diagnosis of schizophrenia according to DSM-5 criteria
2.Continuous hospitalization for more than one year at Kurita Hospital
3.Age under 65 years at the time of the study
Key exclusion criteria
1.Participants whose actigraph wearing rate was less than 80%
2.Deemed unsuitable for participation by the attending psychiatrist or principal investigator
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
3900921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
0262261311
a-tanaka@kuritahp.or.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Tanaka |
Organization
Kurita hospital
Division name
psychiatry
Zip code
3800921
Address
695 Kurita, Nagano City, Nagano Prefecture
TEL
0262261311
Homepage URL
a-tanaka@kuritahp.or.jp
Sponsor or person
Institute
Kurita hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Kurita hospital
Address
695 Kurita, Nagano City, Nagano Prefecture
Tel
0262261311
a-tanaka@kuritahp.or.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
| 2025 | Year | 08 | Month | 07 | 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
17
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study involving chronically hospitalized patients with schizophrenia. It does not involve any intervention and is conducted as an extension of routine clinical practice. The study protocol has been approved by the Ethics Committee of Kurita Hospital (Approval No. 202507), and informed consent has been obtained through an opt-out process. The study registration number is publicly disclosed via in-hospital postings and the hospital website.
Management information
Registered date
| 2025 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067061
