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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023221
Receipt No. R000025816
Scientific Title Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Date of disclosure of the study information 2016/07/19
Last modified on 2018/07/24

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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
Acronym Effect of lipid metabolism genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Scientific Title Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Scientific Title:Acronym Effect of lipid metabolism genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Region
Japan

Condition
Condition Bipolar disorder
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 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 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 "manic" and "depressive" phases (at enrollment)"
Outcome: improve rate of YMRS and MADRS (at 12 week)

"remission" (at enrollment)
Outcome: recurrent rate (YMRS/MADRS >=13)

52 weeks follow up (first visit, 2w, 4w, every 4weeks thereafter)
Key secondary outcomes "manic" and "depressive" phases (at enrollment)"
Response (50% reduction of YMRS/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 YES
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

52 weeks for patients with "remission" (at enrollment)
26 weeks for patients with "manic" and "depressive" phases (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

"manic" or "depressive" phases at enrollment
YMRS>13 (manic) n=20
MADRS>13 (depressive) n=20

"remission" state
YMRS/MADRS<=12 n=20
Key exclusion criteria -Bipolar disorder (rapid cycling) diagnosed by DSM-
-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 or antidepressants
-patients who received more than 3 types of antidepressants (exclude antidepressants which use only as hypnotics)
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nakao Iwata
Organization Fujita Health University School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-98 Dengakugakubo, Kutsukake, AIchi
TEL 0561932639
Email nakao@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Ikeda
Organization Fujita Health University School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-98 Dengakugakubo, Kutsukake, AIchi
TEL 0561932639
Homepage URL
Email ikeda-ma@fujita-hu.ac.jp

Sponsor
Institute Department of Psychiatry, Fujita Health University School of Medicine
Institute
Department

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
Address
Tel
Email

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
2016 Year 07 Month 19 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 Completed
Date of protocol fixation
2016 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 19 Day
Last follow-up date
2018 Year 05 Month 31 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 19 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025816

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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