A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder
Autor: | Cynthia A. Bossie, George M. Simpson, Mary Kujawa, Ibrahim Turkoz, Georges M. Gharabawi, Steven Rodriguez, Robert A. Lasser, Ramy A. Mahmoud |
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Rok vydání: | 2006 |
Předmět: |
Adult
Hospitals Psychiatric Male medicine.medical_specialty Time Factors medicine.drug_class International Cooperation Atypical antipsychotic Schizoaffective disorder Patient Readmission Drug Administration Schedule law.invention Randomized controlled trial Double-Blind Method law Internal medicine medicine Secondary Prevention Humans Longitudinal Studies Prospective Studies Psychiatry Prospective cohort study Risperidone Positive and Negative Syndrome Scale Dose-Response Relationship Drug Dopamine antagonist medicine.disease Psychiatry and Mental health Treatment Outcome Psychotic Disorders Schizophrenia Delayed-Action Preparations Female Schizophrenic Psychology Psychology medicine.drug Antipsychotic Agents |
Zdroj: | The Journal of clinical psychiatry. 67(8) |
ISSN: | 0160-6689 |
Popis: | Objective This study examined the effects of 2 doses of long-acting risperidone injection in patients with schizophrenia or schizoaffective disorder. Method This 52-week, prospective, randomized, double-blind, multicenter, international study included clinically stable outpatients with schizophrenia or schizoaffective disorder (DSM-IV criteria). Settings included physicians' offices and clinics. Patients received a fixed dose of long-acting risperidone (25 or 50 mg) every 2 weeks. Primary outcome was time to relapse, defined as either re-hospitalization or other exacerbation criteria. Other assessments included the Positive and Negative Syndrome Scale, Clinical Global Impressions-Severity of Illness scale, and functional and quality-of-life measures. Safety was assessed via treatment-emergent adverse events, laboratory tests, and movement disorder rating scales. Data were collected from December 2002 to September 2004. Results A total of 324 patients were randomized to 25 mg (N = 163) or 50 mg (N = 161) of long-acting risperidone. Time to relapse was comparable (p = .131) for both groups. Projected median time to relapse was 161.8 weeks (95% CI = 103.0 to 254.2) with 25 mg and 259.0 weeks (95% CI = 153.6 to 436.8) with 50 mg. One-year incidences of relapse were 21.6% (N = 35) and 14.9% (N = 24), respectively (p = .059). Psychiatric hospitalization was the reason for relapse for 16 (10%) in the 25-mg group and 10 (6%) in the 50-mg group. Patients experienced statistically significant but modest improvements at endpoint in most measures (i.e., psychotic symptoms, functioning, movement disorder severity) with both doses, with no significant between-group differences. Conclusion In this 1-year study, long-acting risperidone was associated with low relapse and rehospitalization rates, indicating that doses of 25 to 50 mg are appropriate for long-term treatment in schizophrenia. |
Databáze: | OpenAIRE |
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