UMIN-CTR Clinical Trial

Basic information
Public title	Effect of omega-3 fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders: a prospective observational study
Acronym	Effect of omega-3 fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders: a prospective observational study
Scientific Title	Effect of omega-3 fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders: a prospective observational study
Scientific Title:Acronym	Effect of omega-3 fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders: a prospective observational study
Region	Japan

Condition
Condition	Schizophrenia Major depressive disorder Bipolar disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of effect of omega3-fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders
Basic objectives2	Others
Basic objectives -Others	Examination of effect of omega3-fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Omega3-fatty acid blood level Head MRI Cognitive function
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	Not applicable
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Patients DSM-5 diagnosis of schizophrenia or major depressive disorder or bipolar disorder (2) Healthy controls No current and past history of psychiatric diseases
Key exclusion criteria	Patients and healthy controls with past history of cerebrovascular disease with past history of head injury with fracture of skull or intracranial hemorrhage with metal implants which are not allowed in MRI scan with claustrophobia with pregnancy with serious physical illness who are judged as unsuitable for participation in this study by medical doctor
Target sample size	200

Research contact person
Last name of lead principal investigator	1st name Satoshi Middle name Last name Ukai
Organization	Wakayama Medical University
Division name	Department of Neuropsychiatry
Zip code	641-0012
Address	Kimiidera 811-1, Wakayama
TEL	073-447-2300
Email	cr-psy@wakayama-med.ac.jp

Public contact
1st name of contact person	1st name Shun Middle name Last name Takahashi
Organization	Wakayama Medical University
Division name	Department of Neuropsychiatry
Zip code	641-0012
Address	Kimiidera 811-1, Wakayama
TEL	073-447-2300
Homepage URL
Email	cr-psy@wakayama-med.ac.jp

Sponsor
Institute	Department of Neuropsychiatry, Wakayama Medical University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
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	Research Ethics Committee of Wakayama Medical University
Address	Kimiidera 811-1, Wakayama
Tel	073-447-2300
Email	wa-rinri@wakayama-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	2019 Year 04 Month 15 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	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 08 Day
Date of IRB	2018 Year 02 Month 08 Day
Anticipated trial start date	2019 Year 04 Month 15 Day
Last follow-up date	2023 Year 02 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Examination of effect of omega3-fatty acid blood level on brain network connectivity and cognitive impairment in schizophrenia and mood disorders

Management information
Registered date	2019 Year 04 Month 13 Day
Last modified on	2019 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041418