a pilot study of the use of risperidone long acting injectable in the treatment of patients with recent onset psychosis

Conditions: Schizophrenia

Summary: the purpose of the study is to assess the effectiveness and safety of long-acting injectable risperidone in the treatment of patients in the early stage of psychosis

although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. this study is a pilot project to demonstrate that long-acting risperidone can be used safely and effectively in treating patients in the early stage of psychosis. it is an open-label, single-arm study in patients with recent onset of schizophrenia, schizophreniform disorder, or schizoaffective disorder. there are 3 phases: wash-out phase of 7 days, during which current psychotropic medications are discontinued; oral treatment phase, beginning 1 week before the first injection and continuing 3 weeks thereafter, during which risperidone tablets are taken; and long-acting injectable treatment phase, during which injections are given every 2 weeks for 24 months. assessments of effectiveness include positive and negative syndrome scale (panss), a scale for the measurement of symptoms of schizophrenia; time from initiation of treatment to relapse; calgary depression scale for schizophrenia (cdss), which assesses symptoms of major depressive disorder in patients with schizophrenia; and clinical global impression (cgi) scales. safety assessments include the incidence of adverse events and extrapyramidal symptom rating scale (esrs) scores throughout the study; clinical laboratory tests (hematology and chemistry) and vital signs (pulse, blood pressure, temperature) at stated intervals. risperidone oral tablets once daily (1 milligram\[mg\], 2mg, or 3mg \[maximum\]) from 1 week before first injection through 3 wks after. risperidone injections (25mg, 37.5mg, or 50mg \[max\]) every 2 weeks for 24 months. doses may be increased or decreased at investigator's discretion.

Eligibility criteria:
inclusion criteria: * meet the criteria of the diagnostic and statistical manual of mental diseases, 4th edition (dsm-iv) for schizophreniform disorder, schizophrenia, or schizoaffective disorder for no longer than 12 months, and with not more than two hospitalizations for psychosis * patients who have, during their lifetime, been exposed to a maximum of 12 weeks of antipsychotic medication * patients who will require at least 12 months of treatment exclusion criteria: * dsm-iv axis i diagnosis other than schizophreniform disorder, schizophrenia, or schizoaffective disorder * patients requiring treatment with mood stabilizers or antidepressants at study initiation * alcohol or drug abuse or dependence, according to dsm-iv criteria * history of drug allergy, drug hypersensitivity (including risperidone), or neuroleptic malignant syndrome, a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness * previous treatment with an injectable antipsychotic medication * pregnant or nursing females, or those lacking adequate contraception

Keywords: schizophrenia intramuscular injection antipsychotic agents long-acting risperidone schizophreniform disorders schizoaffective disorder