schizophrenia, schizoaffective disorder, persistent delusional disorder
Conditions
Interventions
(A) Dose increment to the maximum dose of the ongoing antipsychotic drug (1) Phase-I (4 weeks) olanzapine 20 mg/d or risperidone 6 mg/d Other prescribed psychotropic drugs will be kept constant
= 25% decrease in the PANSS will be included in Phase-II. The dose of olanzapine or risperidone will be increased to the maximum dose (i.e., olanzapine 20 mg/d
risperidone 6 mg/d) in an open-label fashion. Also in this phase, other prescribed psychotropic drugs will be kept constant or could be only reduced as clinically appropriate. However, when clinica
Sponsors
Inokashira Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Diagnosis of schizophrenia, schizoaffective disorder, or persistent delusional disorder according to the International Classification of Diseases, 10th Revision (ICD-10) (2) Having been treated with olanzapine 10 mg/d or risperidone 3 mg/d for >= 4 weeks (3) >= 60 on the total score of the PANSS (4) <= 70 on the GAF (5) >= 3 on the CGI-S (6) Being >= 20 years old and competent to contact
Exclusion criteria
Exclusion criteria: (1) Concomitant use of another antipsychotic drug within the last 4 weeks (2) Past history of non-response or intolerability to the maximum dose of the current antipsychotic drug (i.e., olanzapine 20 mg/d; risperidone 6 mg/d) (3) Active suicidal ideations or past suicide attempts (4) Severe physical disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completion rates of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity of Illness (CGI-S), Clinical Global Impression-Global Improvement (CGI-GI), Global Assessment of Functioning (GAF), Functional Assessment for Comprehensive Treatment of Schizophrenia (FACT-Sz), Targeted Inventory on Problems in Schizophrenia (TIP-Sz), Simpson-Angus Scale (SAS), Barnes Akathisia Rating Scale (BAS), Abnormal Involuntary Movement Scale (AIMS), and plasma concentrations of olanzapine or risperidone at week 4 and 8 Prediction of the group allocation by subjects and assessors at week 4 immediately before it is revealed | — |
Countries
Japan
Contacts
Public ContactHitoshi Sakurai
Inokashira Hospital Psychiatry
Outcome results
None listed