UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033503 |
|---|---|
| Receipt number | R000038196 |
| Scientific Title | Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder(2) |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2021/01/25 09:08:08 |
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Basic information
Public title
Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder(2)
Acronym
Effect of lipid metabolism genotypes on the treatment response by PUFA add-on therapy for bipolar disorder(2)
Scientific Title
Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder(2)
Scientific Title:Acronym
Effect of lipid metabolism genotypes on the treatment response by PUFA add-on therapy for bipolar disorder(2)
Region
| Japan |
Condition
Condition
Bipolar Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Sample expansion for the study (R000025816):
To determine the genotype effect of rs28456 (related to the QTL on lipid metabolism) on the treatment response by omega3 PUFA (EPA/DHA) in patients with bipolar disorder
Basic objectives2
Others
Basic objectives -Others
Sample expansion for the study (R000025816):
To explore the genotypes by the genome-wide SNP analysis on the treatment response by omega3 PUFA (EPA/DHA) in patients with bipolar disorder
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
"depressive" phase (at enrollment)"
Outcome: improve rate of MADRS (at 12 week)
"remission" (at enrollment)
Outcome: recurrent rate (YMRS/MADRS >=13)
Maximum 52 weeks follow up (first visit, 2w, 4w, every 4weeks thereafter)
Key secondary outcomes
"depressive" phase (at enrollment)"
Response (50% reduction of MADRS) and non-response rates
Remission (YMRS/MADRS<=12) and non-remission rates
CGI change at the final weeks
RNA/Protein/lipid concentration (Cholesterol/HDL/LDL/TG, omega3 and omega 6 PUFAs)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
DHA/EPA 2g per day
once a day
maximum 52 weeks for patients with "remission" (at enrollment)
maximum 26 weeks for patients with "depressive" phase (at enrollment)
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Bipolar Disorder (I and II) diagnosed by DSM-V
Key exclusion criteria
-Bipolar disorder (rapid cycling) diagnosed by DSM-V
-patients who are taking EPA/DHA
-Allergy for EPA/DHA
-metabolic syndrome at the enrollment
-side effect by EPA/DHA
-high risk of hemorrhage
-patients who received more than 3 types of antipsychotics
-patients who received more than 3 types of antidepressants (exclude antidepressants which use only as hypnotics)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Nakao |
| Middle name | |
| Last name | Iwata |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, AIchi
TEL
0561932639
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Ikeda |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, AIchi
TEL
0561932639
Homepage URL
ikeda-ma@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake
Tel
0562932865
f-irb@fujita-hu.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
| 2018 | Year | 08 | 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
53
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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 25 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038196
