UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051974 |
|---|---|
| Receipt number | R000059317 |
| Scientific Title | Correlation of salivary and blood adiponectin levels in patients with schizophrenia and healthy volunteers |
| Date of disclosure of the study information | 2023/08/23 |
| Last modified on | 2024/02/21 09:18:50 |
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Basic information
Public title
Correlation of salivary and blood adiponectin levels in patients with schizophrenia and healthy volunteers
Acronym
Measurement of salivary and blood adiponectin levels
Scientific Title
Correlation of salivary and blood adiponectin levels in patients with schizophrenia and healthy volunteers
Scientific Title:Acronym
Correlation of salivary and blood adiponectin levels in patients with schizophrenia and healthy volunteers
Region
| Japan |
Condition
Condition
Schizophrenia
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Adiponectin levels in saliva and blood will be measured in patients with schizophrenia and healthy volunteers to examine the correlation between salivary and blood levels.
Basic objectives2
Others
Basic objectives -Others
Adiponectin levels in saliva and blood
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Adiponectin levels in saliva and blood
Key secondary outcomes
Leptin, resistin, TNF-alpha, IL-6, IL-1beta, salivary chromogranin, salivary pH
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Schizophrenic patient part>
1) Patients with schizophrenia who are hospitalized at the Department of Psychiatry, Showa University Karasuyama Hospital and meet DSM-5 diagnostic criteria
2) Patients who are between 20 and 60 years of age at the time of consent.
3) Patients who, after adequate explanation both orally and in writing, obtain consent from the patient if the attending physician determines that the patient is competent to consent, or from a surrogate if the patient is not.
<Healthy volunteers Part>
1) Persons who are between 20 and 60 years of age at the time of obtaining consent
2) Persons who have given written consent to participate in this study
Key exclusion criteria
<Schizophrenic patient part>
1) Patients with a medical history (cerebral organic mental disorder, drug abuse dependence, alcohol abuse/dependence, malignancy, inflammatory bowel disease, heart disease, liver disease, chronic kidney disease, chronic obstructive pulmonary disease) that may affect the evaluation and safety of the study.
2) Those who have symptoms of xerostomia
3) Current smokers or those who have been non-smoking for less than 1 year
4) Subjects who have subjective symptoms of allergic diseases (asthma, atopic dermatitis) and are taking therapeutic drugs for them.
5) Persons who are judged to be ineligible by the physician in charge of the research.
<Healthy volunteers Part>
1) Patients with a medical history (drug abuse/dependence, alcohol abuse/dependence, malignancy, inflammatory bowel disease, heart disease, liver disease, chronic kidney disease, chronic obstructive pulmonary disease) that may affect the evaluation and safety of this study
2) Persons who have been determined by the research physician to have a mental disorder using the Simple Structured Interview Method for Mental Disorders
3) Those who have symptoms of oral dryness
4) Those who are currently smoking or have been smoke-free for less than one year
5) Those who have subjective symptoms of allergic diseases(asthma, atopic dermatitis)and are taking medication to treat them
6) Persons who are judged to be ineligible by the physician in charge of the research
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kiyomi |
| Middle name | |
| Last name | Saito |
Organization
Showa University
Division name
School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8203
kiyomi-s@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyomi |
| Middle name | |
| Last name | Saito |
Organization
Showa University
Division name
School of Pharmacy
Zip code
142-8555
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8203
Homepage URL
kiyomi-s@pharm.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Japan research foundation for clinical pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Karasuyama Hospital Clinical Trial Review Committee
Address
6-11-11 Kitakarasuyama, Setagaya-ku, Tokyo
Tel
03-3300-5247
m-rinri@ofc.showa-u.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
| 2023 | Year | 08 | Month | 23 | 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
40
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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Salivary and blood adiponectin levels will be measured and correlations examined.
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059317
