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Effect of "lipid metabolism" related 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000023221
Enrollment
60
Registered
2016-07-19
Start date
2016-07-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar disorder

Interventions

DHA/EPA 2g per day once a day 52 weeks for patients with &quot
(at enrollment) 26 weeks for patients with &quot
manic&quot
and &quot
phases (at enrollment)&quot

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
"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)

Secondary

MeasureTime frame
"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)

Countries

Japan

Contacts

Public ContactMasashi Ikeda

Fujita Health University School of Medicine Department of Psychiatry

ikeda-ma@fujita-hu.ac.jp0561932639

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026