Unique ID issued by UMIN | UMIN000023221 |
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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 |
Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Effect of lipid metabolism genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Effect of lipid metabolism genotypes on the treatment response by PUFA add-on therapy for bipolar disorder
Japan |
Bipolar disorder
Psychiatry |
Others
YES
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
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
Exploratory
Pragmatic
Not applicable
"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)
"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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
YES
YES
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
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)"
20 | years-old | <= |
64 | years-old | >= |
Male and Female
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
-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)
60
1st name | |
Middle name | |
Last name | Nakao Iwata |
Fujita Health University School of Medicine
Department of Psychiatry
1-98 Dengakugakubo, Kutsukake, AIchi
0561932639
nakao@fujita-hu.ac.jp
1st name | |
Middle name | |
Last name | Masashi Ikeda |
Fujita Health University School of Medicine
Department of Psychiatry
1-98 Dengakugakubo, Kutsukake, AIchi
0561932639
ikeda-ma@fujita-hu.ac.jp
Department of Psychiatry, Fujita Health University School of Medicine
AMED
Government offices of other countries
Japan
NO
2016 | Year | 07 | Month | 19 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 24 | Day |
2016 | Year | 07 | Month | 19 | Day |
2018 | Year | 05 | Month | 31 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 06 | Month | 30 | Day |
2018 | Year | 07 | Month | 31 | Day |
2016 | Year | 07 | Month | 19 | Day |
2020 | Year | 03 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025816
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