Schizophrenia/Schizoaffective Disorder
Conditions
Interventions
Risperidone long-acting injectable (RLAI) group: The patient is injected every two weeks for 6 months, adjunctively with any other antipsychotic(s) except clozapine and ECT. The dose is 25mg, 37.5mg
Sponsors
Department of Psychiatry, Graduate School of Medicine, Chiba University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Schizophrenia or schizoaffective disorder (DSM-4-TR) 2)Criteria of treatment-resistant schizophrenia A)Failure to respond to at least two antipsychotics belonging to two different chemical classes, at dosages equivalent to, or greater than a 600mg/day chlorpromazine equivalent (CPZE)-dose for at least 4 weeks B)Documented diagnosis of tardive dyskinesia (TD), as well as an average yearly Global Assessment of Functioning (GAF) score of less than 61 3)Critera of dopamine supersensitivity psychosis (slightly modified from the Chouinard Research Diagnosis Criteria for Supersensitivity Psychosis: Chouinard, 1990): A)With a treatment history by antipsychotic(s) for over 3 months B)Meeting at least one item from the following dopamine supersensitivity episodes, within one year prior to the study enrollment: (1)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 (2) Tolerance to antipsychotic effects has developed. 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. (3)Relapse episodes cannot be successfully controlled by a 20% increased titration of drug. (4)Psychotic symptoms which are new to the patient, or of greater severity, occurring immediately after a decrease in drug dosage
Exclusion criteria
Exclusion criteria: A)with a treatment history of RLAI injection B)under treatment with clozapine C)under ECT treatment D)with any other Axis 1 or 2 psychiatric disorder E)with clinically severe physical disease F)with pregnancy or suspected pregnancy G)a physician assessed the patient as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brief Psychiatric Rating Scale(BPRS: Overall and Gorham, 1962) | — |
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 Clinical Treatment and Rehabilitation
Outcome results
None listed