UMIN-CTR Clinical Trial

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
Email	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
Email	k-yama@hyo-med.ac.jp

Sponsor
Institute	HYOGO MEDICAL UNIVERSITY
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052918