Schizophrenia, Schizaffective disorder
Conditions
Interventions
Aripiprazole is added with 1.5-mg/day increases every 14 days, in case adjustment of the drug regimen is necessary, during the first and second step as follows. 1. The first step is the aripiprazole
s clinical status, until the best drug dose of both aripiprazole (max. dose is 30 mg/day) and other neuroleptic(s) are fixed. 3. The third step is the aripiprazole observational phase. The fixed drug
Sponsors
Department of Psychiatry, Chiba University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Satisfaction of DSM-4-TR criteria for schizophrenia (295.XX) or schizoaffective disorder (295.70). 2)Occurence of at least one episode of dopamine supersensitivity psychosis as follows, within the prior year. A)Acute relapse or exacerbation of psychosis appearing after a dose reduction or discontinuation of antipsychotics, within 6 weeks for oral medication or 3 months for intramuscular medication. B)Development of tolerance to antipsychotic effects. This is defined as when an acute relapse or exacerbation of psychosis occurs, independent of a dose reduction or discontinuation of antipsychotic therapy and stable psychotic state. C)Relapse episodes cannot be successfully controlled by a 20% increased titration of drug. D)Psychotic symptoms which are new to the patient, or of greater severity, occuring immediately after a decrease in drug dosage. 3)Age at the consent to study participation within the range of 20 to 60 years. 4)No alteration of content/dosage/usage of taken antipsychotics in the 4 weeks prior to the study initiation. 5)The patient himself/herself understands all of the study content and agrees the study particiation with a written informed consent. If the study physician judges that the patients cannot understand the study due to his/her disease status, written consent by his/her guardian such as parent or spouse is possible.
Exclusion criteria
Exclusion criteria: 1)Under treatment with clozapine 2)A treatment history of ECT in the 3 months prior to the study enrollment 3)In a coma state 4)Under profound effects by CNS inhibition drugs such as barbiturates or anesthetic agent 5)Under treatment with adrenergic agent 6)Hypersensitivity to any content in the trial drug 7)Lacking notification of diagnosis 8)Presence of any other Axis 1 or 2 psychiatric disorder according to DSM-4-TR 9)Pregnant or suspected of pregnancy 10)Participation history of a clinical trial with any intervention (i.e., except for observational study), within recent 3 months prior to the study enrollment 11)With suicide history within the 1 year proor to the study enrollment 12)Assessment as unsuitable for participation in the study by the study physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale(PANSS: Kay et al., 1981) | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Assessment of Functioning (GAF) Clinical Global Impression Scale-Severity/-Change Extrapyramidal Symptom Rating Scale (ESRS: Chouinard and Margolese, 2005) | — |
Countries
Japan
Contacts
Public ContactNobuhisa Kanahara
Chiba University Center for Forensic Mental Health Division of Medical Treatment and rehabilitation
Outcome results
None listed