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Stable elderly patients with psychotic disorders improve with long-acting risperidone
282 to show a direct correlation between degree of partial compliance and clinical outcome and strongly support the importance of strategies and technologies of care that promote continuous medication treatment with an atypical antipsychotic.
CLINICAL AND FUNCTIONAL STATUS OVER THE FIRST THREE MONTHS OF TREATMENT: RESULTS FROM THE SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES (SOHO) STUDY E. T. Edgell,* J. M. Haro, R Frewer, R Wright Lilly Research Centre, Eli Lilly and Company Limited, Windlesham, Surrey, United Kingdom OBJECTIVE: To describe changes in clinical and functional status and associated use patterns over the first 3 months of treatment across antipsychotics used in actual outpatient settings. METHODS: Mean change in positive, negative, cognitive, depressive, and overall symptoms from baseline to 3 months were measured using the Clinical Global Impression Schizophrenia (CGI-SCH) scale for patients enrolled in the Schizophrenia Outpatient Health Outcomes (SOHO) study. Change in functional status was examined by comparing the proportion of patients socialising with friends and family at baseline and 3 months. Dose and rates of treatment continuation, modification, and anticholinergic use or EPS were also assessed. SOHO is a 3-year, prospective, outpatient, Pan-European, observational study of health outcomes associated with antipsychotic treatment. Patients were enrolled upon initiation of or change to a new antipsychotic in actual outpatient treatment settings. RESULTS: Total enrolment in SOHO was 10,972 patients across 10 European countries. Three month data was collected on 9,573 patients. Mean change in positive symptoms was less for quetiapine patients (-0.54_+1.17) than for other cohorts (ranged from 0.69-+1.33 to -1.19+1.30). Mean change in negative symptoms was greater for olanzapine (-0.74_+1.06) and clozapine (-0.74-+1.09) than for other cohorts (ranged from -0.38_+0.94 to -0.58-+1.05). At least 40% of patients in the risperidone or typical cohorts were taking anticholinergics or experiencing EPS at 3 months. Social functioning improved across all cohorts with the biggest improvements seen in olanzapine treated patients. CONCLUSIONS: Substantial improvements in clinical status were seen from baseline to 3 months across all antipsychotics. Quetiapine treated patients had the smallest reduction in positive symptoms. Patients treated with risperidone and typical antipsychotics were more likely to be treated with an anticholinergic or experience extrapyramidal symptoms compared to patients treated with other antipsychotics. Patients treated with olanzapine or clozapine experienced the largest reductions in negative symptoms which in turn may have led to greater improvements in social functioning compared to patients treated with other antipsychotics.
STABLE ELDERLY PATIENTS WITH PSYCHOTIC DISORDERS IMPROVE WITH LONG-ACTING RISPERIDONE M. E e r d e k e n s , * R. Lasser, C. Bossie, Y. Zhu, G. G h a r a b a w i
Janssen Research Foundation, Belgium, Belgium Oral atypical antipsychotics are commonly used in elderly patients with psychotic disorders. These agents provide an improved bene-
18. Therapeutics: Treatment Trials fit/risk ratio compared with conventional neuroleptics but have been available only in short-acting formulations, requiring daily dosing. Risperidone microspheres, the first long-acting injectable atypical antipsychotic, was assessed in elderly patients with psychotic disorders. An open-label study of risperidone microspheres included elderly patients (->65 years of age) with schizophrenia or schizoaffective disorders judged to be symptomatically stable. Patients were assigned by clinician's judgment to 25, 50, or 75 mg of long-acting risperidone every 2 weeks for up to 50 weeks. Fiftyseven elderly patients (mean [SE] age, 70.9 _+ 0.68 years) were enrolled. Mean PANSS total score showed significant symptom improvement throughout the 50 weeks and at end point. There were significant improvements on PANSS positive, negative, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression scores at endpoint. Although patients were judged to be clinically stable at study entry, 49.0% realized clinical improvement (_>20% PANSS total score reduction), and 54.5% improved on CGI ratings at endpoint. The severity of extrapyramidal symptoms were improved or unchanged at endpoint. Adverse events seen in >10% of patients were insomnia (10.5%), constipation (10.5%), and bronchitis (12.3%). The incidence of adverse events was not dose related. Vital sign and electrocardiographic changes were not clinically relevant. Mean weight increased 0.3 kg at end point. These data suggest that long-acting risperidone can safely provide continued symptom improvement in stable elderly patients with psychotic disorders.
PREMORBID FUNCTIONING AS A PREDICTOR OF CLOZAPINE RESPONSE IN TREATMENT REFRACTORY SCHIZOPHRENIA S. M. F e l d m a n , * E. A. Gale, D. L. Kelly, Y. Yu, C. M. Richardson, R. R. C o n l e y
Maryland Psychiatric Research Center, University of Maryland, Baltimore, MD, USA It is recognized that early successful treatment can improve outcomes and generally improve recovery potential for those with schizophrenia. Thus, clinical variables associated with favorable treatment response may have important clinical application. Poor premorbid functioning has been found to be related to poor antipsychotic response for conventional antipsychotics but very little data exists on this topic. This study compares the premorbid functioning among patients who responded to clozapine treatment(N=35)and those who responded poorly(N=50). Patients were considered to have responded if they had a 20% decrease in BPRS score. All patients were treated openly with clozapine for a minim u m of eight weeks in an inpatient setting. Premorbid functioning was assessed using the Premorbid Adjustment Scale. Patients who did not respond to clozapine had a tendency to be less social and more withdrawn during early childhood(prior to age 11)(p=0.08). The poor responders also had fewer peer relationships and more deviant friendship patterns and more difficulty with school adaptation in early life. While age of illness onset was not significantly different,poor responders were slightly younger at illness onset(18 vs. 21 years) and they had a more insidious onset to their illness(p=0.04). The clinical implications of these findings should encourage further examination of early childhood indicators and opportunities for appropriate and effective intervention.
International Congress on Schizophrenia Research 2003
CLINICAL AND FUNCTIONAL STATUS OVER THE FIRST THREE MONTHS OF TREATMENT: RESULTS FROM THE SCHIZOPHRENIA OUTPATIENT HEALTH OUTCOMES (SOHO) STUDY E. T. Edgell,* J. M. Haro, R Frewer, R Wright Lilly Research Centre, Eli Lilly and Company Limited, Windlesham, Surrey, United Kingdom OBJECTIVE: To describe changes in clinical and functional status and associated use patterns over the first 3 months of treatment across antipsychotics used in actual outpatient settings. METHODS: Mean change in positive, negative, cognitive, depressive, and overall symptoms from baseline to 3 months were measured using the Clinical Global Impression Schizophrenia (CGI-SCH) scale for patients enrolled in the Schizophrenia Outpatient Health Outcomes (SOHO) study. Change in functional status was examined by comparing the proportion of patients socialising with friends and family at baseline and 3 months. Dose and rates of treatment continuation, modification, and anticholinergic use or EPS were also assessed. SOHO is a 3-year, prospective, outpatient, Pan-European, observational study of health outcomes associated with antipsychotic treatment. Patients were enrolled upon initiation of or change to a new antipsychotic in actual outpatient treatment settings. RESULTS: Total enrolment in SOHO was 10,972 patients across 10 European countries. Three month data was collected on 9,573 patients. Mean change in positive symptoms was less for quetiapine patients (-0.54_+1.17) than for other cohorts (ranged from 0.69-+1.33 to -1.19+1.30). Mean change in negative symptoms was greater for olanzapine (-0.74_+1.06) and clozapine (-0.74-+1.09) than for other cohorts (ranged from -0.38_+0.94 to -0.58-+1.05). At least 40% of patients in the risperidone or typical cohorts were taking anticholinergics or experiencing EPS at 3 months. Social functioning improved across all cohorts with the biggest improvements seen in olanzapine treated patients. CONCLUSIONS: Substantial improvements in clinical status were seen from baseline to 3 months across all antipsychotics. Quetiapine treated patients had the smallest reduction in positive symptoms. Patients treated with risperidone and typical antipsychotics were more likely to be treated with an anticholinergic or experience extrapyramidal symptoms compared to patients treated with other antipsychotics. Patients treated with olanzapine or clozapine experienced the largest reductions in negative symptoms which in turn may have led to greater improvements in social functioning compared to patients treated with other antipsychotics.
STABLE ELDERLY PATIENTS WITH PSYCHOTIC DISORDERS IMPROVE WITH LONG-ACTING RISPERIDONE M. E e r d e k e n s , * R. Lasser, C. Bossie, Y. Zhu, G. G h a r a b a w i
Janssen Research Foundation, Belgium, Belgium Oral atypical antipsychotics are commonly used in elderly patients with psychotic disorders. These agents provide an improved bene-
18. Therapeutics: Treatment Trials fit/risk ratio compared with conventional neuroleptics but have been available only in short-acting formulations, requiring daily dosing. Risperidone microspheres, the first long-acting injectable atypical antipsychotic, was assessed in elderly patients with psychotic disorders. An open-label study of risperidone microspheres included elderly patients (->65 years of age) with schizophrenia or schizoaffective disorders judged to be symptomatically stable. Patients were assigned by clinician's judgment to 25, 50, or 75 mg of long-acting risperidone every 2 weeks for up to 50 weeks. Fiftyseven elderly patients (mean [SE] age, 70.9 _+ 0.68 years) were enrolled. Mean PANSS total score showed significant symptom improvement throughout the 50 weeks and at end point. There were significant improvements on PANSS positive, negative, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression scores at endpoint. Although patients were judged to be clinically stable at study entry, 49.0% realized clinical improvement (_>20% PANSS total score reduction), and 54.5% improved on CGI ratings at endpoint. The severity of extrapyramidal symptoms were improved or unchanged at endpoint. Adverse events seen in >10% of patients were insomnia (10.5%), constipation (10.5%), and bronchitis (12.3%). The incidence of adverse events was not dose related. Vital sign and electrocardiographic changes were not clinically relevant. Mean weight increased 0.3 kg at end point. These data suggest that long-acting risperidone can safely provide continued symptom improvement in stable elderly patients with psychotic disorders.
PREMORBID FUNCTIONING AS A PREDICTOR OF CLOZAPINE RESPONSE IN TREATMENT REFRACTORY SCHIZOPHRENIA S. M. F e l d m a n , * E. A. Gale, D. L. Kelly, Y. Yu, C. M. Richardson, R. R. C o n l e y
Maryland Psychiatric Research Center, University of Maryland, Baltimore, MD, USA It is recognized that early successful treatment can improve outcomes and generally improve recovery potential for those with schizophrenia. Thus, clinical variables associated with favorable treatment response may have important clinical application. Poor premorbid functioning has been found to be related to poor antipsychotic response for conventional antipsychotics but very little data exists on this topic. This study compares the premorbid functioning among patients who responded to clozapine treatment(N=35)and those who responded poorly(N=50). Patients were considered to have responded if they had a 20% decrease in BPRS score. All patients were treated openly with clozapine for a minim u m of eight weeks in an inpatient setting. Premorbid functioning was assessed using the Premorbid Adjustment Scale. Patients who did not respond to clozapine had a tendency to be less social and more withdrawn during early childhood(prior to age 11)(p=0.08). The poor responders also had fewer peer relationships and more deviant friendship patterns and more difficulty with school adaptation in early life. While age of illness onset was not significantly different,poor responders were slightly younger at illness onset(18 vs. 21 years) and they had a more insidious onset to their illness(p=0.04). The clinical implications of these findings should encourage further examination of early childhood indicators and opportunities for appropriate and effective intervention.
International Congress on Schizophrenia Research 2003