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omega3 PUFA add-on therapy for bipolar disorder: genotype stratified analysis

Effect of "lipid metabolism" related genotypes on the treatment response by PUFA add-on therapy for bipolar disorder - omega3 PUFA add-on therapy for bipolar disorder: genotype stratified analysis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180075
Enrollment
60
Registered
2019-03-11
Start date
2016-08-10
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

PUFA add-on therapy

Sponsors

Iwata Nakao
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Bipolar Disorder (I and II) diagnosed by DSM-V

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
"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)

Secondary

MeasureTime frame
"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)

Contacts

Public ContactMsashi Ikeda

Fujita Health University Hospital

ikeda-ma@fujita-hu.ac.jp+81-562-93-9250

Outcome results

None listed

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