UMIN-CTR Clinical Trial

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
Email	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
Email	ikeda-ma@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
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	Fujita Health University
Address	1-98 Dengakugakubo, Kutsukake
Tel	0562932865
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038196