Treatment resistant bipolar depression
Conditions
Interventions
The patients receive single-blind, adjunctive placebo for 2 weeks after patients achieve adequate dose or target blood levels. When it is not fully responded with mood stabilizers (lithium valproate,
Sponsors
Kansai Medical University
Department of Psychiatry, University of Occupational and Environmental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Screening phase Patients who meet DMS-IV-TR criteria for bipolar disorder Both male and female outpatients/inpatients aged at 18-65 years. Patients who have a MADRS total score of 20 or greater and a YMRS total score of 12 or less at baseline. Patients who have received mood stabilizers (Li, VPA, or LTG) for 4 weeks prior to this study. Patients who have achieved serum Li levels of 0.7 mEq/L or blood VPA levels of 50 ug/mL.. Patients who have received LTG at 200 mg/day or greater for 2 weeks. Patients providing written informed consent. 2) Double-blind phase (adjunctive phase) Patients who meet the above inclusion criteria. Patients who have a MADRS total score of 20 or greater and a YMRS total score of 12 or less at baseline. Patients who have less than 20% improvement in MADRS for the screening phase.
Exclusion criteria
Exclusion criteria: Patients who meet DSM-IV-TR for significant Axis I and II disorders except bipolar disorder. Patients who received antipsychotics or antidepressants within 4 weeks prior to screening phase. Patients who have a ECT therapy within 3 months prior to screening phase. Patients who are comatose and strongly affected by central nervous system depressants such as barbiturates or anesthetics. Patients who have received adrenaline. Patients known to have a history or complication of allergy to aripiprazole. Patients with a history or a complication of diabetes. Women who are pregnant, possibly pregnant, or breast-feeding. Patients who have been judged by the investigator to be inappropriate for inclusion in the trial for any other reasons Patients who have a complication of serious physical disorder. Patients who have been judged by the investigators to have a high risk of suicide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of Montgomery-Asberg Depression Rating Scale (MADRS) for 8 weeks in double-blind phase (from Week 2 to Week 10) in aripiprazole group and placebo group (LOCF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change of The Japanese version of Young Mania rating scale (YMRS-J), Clinical global impression;Severity (CGI-S) and Quick Inventory of Depressive Symptomatology (QIDS-J) (at Week 2, 6, 10) Mean change of Body mass index (BMI), body weight, and laboratory values (at Week 2, 10) | — |
Countries
Japan
Contacts
Public ContactMASAKI KATO
Kansai Medical University Department of Neuropsychiatry
Outcome results
None listed