treatment-resistant bipolar disorder
Conditions
Interventions
lacosamide200mg/day
Sponsors
Fujita Health University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients did not improve their symptoms using at least one mood stabilizer with adequate dose for 4 weeks or more than 4 weeks. Patients did not improve their symptoms using at least one second generation antipsychotic with adequate dose for 4 weeks or more than 4 weeks. Patients did not improve their symptoms using combination therapy of mood stabilizer with second generation antipsychotic with adequate dose for 4 weeks or more than 4 weeks.
Exclusion criteria
Exclusion criteria: no neurological or systemic diseases, including disturbance of hematopoiesis no history of electroconvulsive therapy within 6 months prior to study enrollment absence of pregnancy no dependence on any addictive substances other than nicotine in the past 5 years before enrollment no suicidal ideation and suicidal attempt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Global Impression-Severity score from baseline to endpoint (12 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Young Mania Rating Scale, Hamilton Rating Scale for Depression, discontinuation rate, incidence of individual adverse events | — |
Countries
Japan
Contacts
Public ContactTaro Kishi
Fujita Health University School of Medicine Psychiatry
Outcome results
None listed