Bipolar Disorder
Conditions
Interventions
DHA/EPA 2g per day once a day maximum 52 weeks for patients with "
(at enrollment) maximum 26 weeks for patients with "
phase (at enrollment)
Sponsors
Fujita Health University
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
| Measure | Time 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
| Measure | Time 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) | — |
Countries
Japan
Contacts
Public ContactMasashi Ikeda
Fujita Health University School of Medicine Department of Psychiatry
Outcome results
None listed