UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036498 |
|---|---|
| Receipt number | R000041418 |
| Scientific Title | Effect of omega-3 fatty acid on brain network connectivity and cognitive impairment in schizophrenia and mood disorders: a prospective observational study |
| Date of disclosure of the study information | 2019/04/15 |
| Last modified on | 2019/04/13 13:53:09 |
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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
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
cr-psy@wakayama-med.ac.jp
Public contact
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
cr-psy@wakayama-med.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041418
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
