UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023221
Receipt number 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 2020/03/06 22:22:30

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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 or person

Institute

Department of Psychiatry, Fujita Health University School of Medicine

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


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

2020 Year 03 Month 06 Day



Link to view the page

Value
https://center6.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