Treatment-resistant depression with or without mixed feature.
Conditions
Interventions
switching to different antidepressants for 6 weeks.
aripiprazole augmentation for 6 weeks.
Sponsors
Kansai Medical University, Osaka, Japan
University of Occupational and Environmental Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Screening phase Patients who meet DMS-5 criteria for major depressive disorder. Both male and female outpatients/inpatients aged at 20-65 years. Patients who have a HAM-D17 total score of 17 or greater. Rater-blind RCT phase Patients who meet DMS-5 criteria for major depressive disorder. Both male and female outpatients/inpatients aged at 20-75 years. Patients who have a HAM-D17 total score of 17 or greater and less than 50% improvement in HAM-D17 for the screening phase(taking stable SSRI, SNRI or mirtazapine therapy for 6 weeks.)
Exclusion criteria
Exclusion criteria: Patients who meet DSM5 for significant Axis I and II disorders except major depressive disorder. Patients who have a ECT therapy within 3 months prior to study entree. Patients who are comatose and strongly affected by central nervous system. 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 been judged by the investigators to have a high risk of suicide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate and percent change of Hamilton rating scale for depression 17 (HAM-D17) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function test, NEO-FFI, Home Environment Questionarie | — |
Countries
Japan
Contacts
Public ContactMasaki Kato
Kansai Medical University, Osaka, Japan Department of Neuropsychiatry
Outcome results
None listed