UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046381 |
|---|---|
| Receipt number | R000052918 |
| Scientific Title | The investigation of immunoligical and molecular mecahanisms between obsessive-compulsive disorder and its comorbidity. |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2021/12/15 11:08:15 |
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Basic information
Public title
The investigation of immunoligical and molecular mecahanisms between obsessive-compulsive disorder and its comorbidity.
Acronym
The investigation of immunoligical and molecular mecahanisms between obsessive-compulsive disorder and its comorbidity.
Scientific Title
The investigation of immunoligical and molecular mecahanisms between obsessive-compulsive disorder and its comorbidity.
Scientific Title:Acronym
The investigation of immunoligical and molecular mecahanisms between obsessive-compulsive disorder and its comorbidity.
Region
| Japan |
Condition
Condition
obsessive-compulsive disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Obsessive-compulsive disorder has a lifetime prevalence of 1 to 2%, and the average age of onset is around 20 years old, which is a young onset, and is a disease that greatly affects the life of patients. In recent years, in addition to immunological mechanisms, the existence and intractability of comorbid diseases such as neurodevelopmental disorders such as autism spectrum disorders, attention deficit hyperactivity disorder, and tic-related disorders have been pointed out. Therefore, the purpose of this study is to elucidate the mechanism of immunological involvement depending on the presence or absence of obsessive-compulsive disorder and their comorbidities, and to elucidate the mechanism by the difference in expression of immune-related genes as the elucidation of the intractable mechanism.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cytokines
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have been diagnosed with obsessive-compulsive disorder based on the 5th edition of the American Psychiatric Association's Diagnostic and Statistical Manual of Psychiatric Disorders, who are in the Department of Psychiatry and Neurology, Hyogo Medical University Hospital, have diagnostic criteria for autism spectrum disorder. Those who meet, those who meet the diagnostic criteria for obsessive-compulsive disorder, and those who meet the diagnostic criteria for tic disorder or Tourette's disorder. In addition, the person who can understand the purpose of this study by the attending physician, is judged to be able to participate, and has given free will consent in writing.
Those who have been admitted to the Department of Psychiatry and Neurology, Hyogo College of Medicine Hospital, and have been diagnosed with compulsive disorder based on the 5th edition of the American Psychiatric Association's Psychiatric Disorder Diagnosis and Statistics Manual, and other mental disorders. Those who do not meet the diagnostic criteria. In addition, the person who can understand the purpose of this study by the attending physician, is judged to be able to participate, and has given free will consent in writing.
Key exclusion criteria
Those who do not get consent, those who the attending physician admits that there is a problem with consent ability, those who admit significant excitement, violence, drug dependence / abuse, patients with severe heart failure, liver failure, etc.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hisato |
| Middle name | |
| Last name | Matunaga |
Organization
HYOGO MEDICAL UNIVERSITY
Division name
Department of Psychiatry
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798456111
hisa1311@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kyosuke |
| Middle name | |
| Last name | Yamanishi |
Organization
HYOGO MEDICAL UNIVERSITY
Division name
Department of Psychiatry
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
TEL
0798456111
Homepage URL
k-yama@hyo-med.ac.jp
Sponsor or person
Institute
HYOGO MEDICAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
HYOGO MEDICAL UNIVERSITY
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
HYOGO MEDICAL UNIVERSITYDepartment of Psychiatry
Address
1-1 Mukogawa-cho, Nishinomiya-shi, Hyogo
Tel
0798456111
k-yama@hyo-med.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
| 2022 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluation of clinical symptoms by a skilled psychiatrist (psychiatrist) for patients with compulsive disorder who attended the Department of Psychiatry and Neurology, Hyogo College of Medicine Hospital and were able to obtain written informed consent while in the hospital. conduct. Then, collect 2 bottles of blood (10 ml each, 20 ml in total). Serum is separated from one and blood cytokines are measured. Peripheral blood mononuclear cells) are isolated from the remaining one, total RNA is extracted and purified, and gene analysis is performed using a microarray.
Management information
Registered date
| 2021 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052918
