Schizophrenia
Conditions
Interventions
Blonanserin as add-on therapy
Olanzapine as add-on therapy
Sponsors
Chiba University Hospital Clinical Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Diagnosed as a schizophrenia (DSM-IV-TR) 2)[Criteria for DSP]Treated with antipsychotics for at least 3 months 3)[Criteria for DSP] Relapse/exacerbation of psychosis in the past year under any of the following conditions: a) Relapse/exacerbation within 6 weeks after reduction/discontinuance/non-adherence of oral antipsychotics b) Relapse/exacerbation within 3 months after reduction/discontinuance/non-adherence of long acting injectable antipsychotics c) Failure to control relapse/exacerbation using 20% increased dose of antipsychotics d) New symptoms/severe exacerbation induced by reduction/discontinuance/non-adherence/replacement of antipsychotics 4) Total score of PANSS at baseline >= 78 5) Stable antipsychotic treatment for the 4 weeks before providing informed consent 6) Providing an informed consent
Exclusion criteria
Exclusion criteria: 1)[Criteria for DSP] First episode schizophrenia 2)[Criteria for DSP] Unstable and continuous severe psychotic symptoms under antipsychotic treatment for more than 3 months 3))[Criteria for DSP] Deficit syndrome 4)Contraindication to blonanserin/olanzapine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total score of the Positive and Negative Symptoms Scale (PANSS) between baseline and endpoint (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| <Efficacy> 1) Before administration and 3 and 6 months after the start of administration: -Change in daily dose of all antipsychotic drugs (calculated as chlorpromazine) 2) 3 months and 6 months after the start of administration: -Dropout rate -Monotherapy ratio -PANSS (Positive Scale, Negative Scale, Comprehensive Psychopathology Scale) -CGI-S -Concomitant drugs <Safety> 1) Before administration and 6 months after administration (final observation point/at the time of discontinuation): -ESRS -Adverse events -Weight change -Changes in blood test items: Biochemistry (GOT, GPT, LDH, gamma-GTP, T-Bil, CPK, BUN, Cr, Na, K, Cl, CRP, T-Cho, TG, fasting (any time) blood glucose, HbA1c, prolactin), blood Arithmetic (WBC, RBC, Hb, Plt) -ECG (change in QTc interval) 2) 1 month, 2 months, 3 months after the start of administration: -ESRS -Adverse events -Weight change | — |
Countries
Japan
Contacts
Public ContactTomihisa Niitsu
Chiba University Graduate School of Medicine Department of Psychiatry
Outcome results
None listed