Bipolar disorder
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Fujita Health University School of Medicine Department of Psychiatry