PMID- 15933481 OWN - NLM STAT- MEDLINE DCOM- 20051004 LR - 20211203 IS - 0268-1315 (Print) IS - 0268-1315 (Linking) VI - 20 IP - 4 DP - 2005 Jul TI - Lack of impact of race on the efficacy and safety of long-acting risperidone versus placebo in patients with schizophrenia or schizoaffective disorder. PG - 207-12 AB - This analysis aimed to assess the relationship between race and clinical response to long-acting, injectable risperidone treatment in patients with schizophrenia or schizoaffective disorder. In a 12-week, randomized, double-blind study, patients with schizophrenia or schizoaffective disorder received placebo or long-acting risperidone (25, 50 or 75 mg every 2 weeks). Data were stratified by race as identified by demographic information: Caucasian, African-American or Other. Psychotic symptoms were assessed by the Positive and Negative Syndrome Scale (PANSS); movement disorders by the Extrapyramidal Symptom Rating Scale (ESRS); adverse events (AEs) were reported spontaneously. Data were available for 439 patients: 193 Caucasian (44%), 174 (40%) African-American and 72 (16%) Other patients. Baseline characteristics were similar between racial groups, as were study completion rates (overall: 30% placebo; 48% long-acting risperidone). There was a significant effect of treatment (P<0.001), but not of race, on improvement in PANSS total scores from baseline to endpoint. ESRS scores were low throughout the study, and no significant impact of race was observed. Overall rates of AEs were similar among the racial groups. Race did not appear to impact the efficacy and tolerability of long-acting risperidone. FAU - Ciliberto, Natalie AU - Ciliberto N AD - Medical Services CNS, Medical Affairs Division, Janssen Pharmaceutica, Inc, Titusville, New Jersey 08560, USA. nciliber@janus.jnj.com FAU - Bossie, Cynthia A AU - Bossie CA FAU - Urioste, Ronald AU - Urioste R FAU - Lasser, Robert A AU - Lasser RA LA - eng PT - Clinical Trial PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Int Clin Psychopharmacol JT - International clinical psychopharmacology JID - 8609061 RN - 0 (Antipsychotic Agents) RN - 0 (Delayed-Action Preparations) RN - 0 (Placebos) RN - L6UH7ZF8HC (Risperidone) SB - IM MH - Adult MH - Antipsychotic Agents/administration & dosage/*adverse effects/*therapeutic use MH - Delayed-Action Preparations MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Placebos MH - Psychotic Disorders/*drug therapy/*ethnology MH - *Racial Groups MH - Risperidone/administration & dosage/*adverse effects/*therapeutic use MH - Schizophrenia/*drug therapy/*ethnology MH - Treatment Outcome EDAT- 2005/06/04 09:00 MHDA- 2005/10/05 09:00 CRDT- 2005/06/04 09:00 PHST- 2005/06/04 09:00 [pubmed] PHST- 2005/10/05 09:00 [medline] PHST- 2005/06/04 09:00 [entrez] AID - 00004850-200507000-00003 [pii] AID - 10.1097/00004850-200507000-00003 [doi] PST - ppublish SO - Int Clin Psychopharmacol. 2005 Jul;20(4):207-12. doi: 10.1097/00004850-200507000-00003.