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Initial treatment of acutely exacerbated and highly agitated schizophrenic patients with risperidone
298 A NATURALISTIC STUDY OF RESPONSE TO CLOZAPINE FOLLOWING FAILURE TO RESPOND TO OLANZAPINE S. A. Osborne,* J. C. Mum'o, C. S t e p h e n s o n , I. C h a u d h r y , N. Fisher, R. W. K e r w i n
Division of Psychological Medicine, Institute of Psychiatry, King, London, UnitedKingdom (a) The aim of the study was to assess clinical response to clozapine following failure to respond to olanzapine, in patients with schizophrenia or schizoaffective disorder. (b) The study was of a naturalistic design. Individuals who had failed to respond adequately, in the opinion of the responsible clinician, to at least 6 weeks treatment with olanzapine, and who were commencing clozapine as part of their routine clinical management, were the subject group. Standard ratings of clinical state including the Brief Psychiatric Rating Scale (BPRS) were made prior to clozapine initiation and at 6, 12 and 26 weeks of clozapine treatment. A positive response to clozapine was defined a priori as an improvement in BPRS score of at least 20% after 26 weeks treatment with clozapine. (c) 20 subjects were recruited, 13 (65%) completed 26 weeks treatment and 7 (35%) ddropped out of the study. Of the 13 subjects who completed 26 weeks clozapine treatment, 5 (39%) responded to clozapine according to the study criteria of improvement in BPRS score of at least 20%. Of the 7 subjects who dropped out of the study, the main reason was non-compliance with clozapine due to adverse drug effects in 5 (71%) cases. None of the subjects who dropped out of the study improved, according to rating scale scores of clinical response. (d) The conclusion reached from this study is that in a naturalistic setting, failure to respond to olanzapine did not predict failure to respond to clozapine, indicating that despite the similar in vitro pharmacological properties of the two drugs, there are in vivo differences resulting in differing clinical efficacy. This work was supported by a research grant fi'om Novartis Pharmaceuticals UK Ltd
INITIAL TREATMENT OF ACUTELY EXACERBATED AND HIGHLY AGITATED SCHIZOPHRENIC PATIENTS WITH RISPERIDONE E G. Pajonk,* A. Schreiner, S. Peters, E. R u e t h e r
Universitaetsnervenklinik, UniversityHospitals of Saarland, Homburg, Germany Objective: The effectiveness of atypical antipsychotic agents in the treatment of acute schizophrenic episodes is still a subject of" controversial debate. The objective, therefore, was to investigate the efficacy and tolerability of an initial treatment with the atypical antipsychotic agent risperidone in acutely exacerbated patients under the conditions of clinical practice. A sub-analysis was performed to evaluate if highly agitated and aggressive patients may profit from an initial risperidone therapy as well. Material and Methods: In a prospective multicenter observational trial, schizophrenic patients with acute exacerbations tretaed with risperidone within 24 hours of in-patient admission were observed for up to 6 weeks. Patients showing a total score of >15 in the items excitement, hostility and uncooperativeness of the Positive and Negative Syndrome Scale (PANSS) were defined as highly agitated patients. Evaluation of efficacy was carried out according to a modified PANSS, the Clinical Global Impression (CGI) and the Brief Psychiatric Rating Scale (BPRS). Results: 1,625 patients were evaluated. An improvement of all parameters was shown in the whole study group (50% males; age
18. Therapeutics: Treatment Trials 40.5_+15.0 years, paranoid schizophrenia in 67.7% of cases) and in particular in the subgroup of highly agitated patients. In these patients (n=256; 15.7%) a greater improvement in symptoms was observed. Only in 3.7% of patients was risperidone discontinued because of side effects. At the end of the observation, the mean dosage was 4.7 mg/d in the total group and 4.8 mg/d in the highly agitated patients (p=0.54). More than 55% of the patients were finally treated with a risperidone monotherapy. Conclusion: The initial treatment with risperidone proves to be effective and safe even for highly agitated schizophrenic patients under the conditions of clinical practice.
RANDOM-ASSIGNMENT, DOUBLE-BLIND, CLINICAL TRIAL OF ONCE- VERSUS TWICEDAILY ADMINISTRATION OF QUETIAPINE IN PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER H. Parepally,* K. N. Chengappa, J. S. Brar, J. Mullen, A. Schilling, J. M. Goldstein
Psychiatry, WesternPsychiatric, Pittsburgh, PA, USA The purpose of this study was to evaluate the efficacy and safety of administering quetiapine once versus twice daily. Using a doubleblind design, 21 hospitalized patients with schizophrenia (n=7) or schizoaffective disorder (n=14) who had received unchanged dosages (for 2 weeks) of either 400 mg or 600 mg of quetiapine administered twice dally were randomized to once- or twice-daily administration for 4 weeks and then crossed-over to the opposite regimen for an additional 4 weeks. Patients receiving mood stabilizers or antidepressants for schizoaffective disorder remained on those agents. Standard psychopathology and safety measures were used. We found that nearly 70% (15/21) of the patients met a priori efficacy responder criteria with no statistical differences in response between those assigned to a once- or twice-daily dosing schedule. Other statistical analyses confirmed that the majority of patients tolerated the switch to once- or twice-daily administration with quetiapine. A minority experienced worsening of symptoms or orthostatic hypotension during the crossover. Results suggest that it is clinically feasible to switch a majority of quetiapine-treated patients receiving a twicedaily regimen to a once-daily regimen. Quetiapine was generally well tolerated at either dosing schedule. The strategy of administering quetiapine once daily at bedtime may promote improved adherence to treatment.
EFFICACY A N D SAFETY OF OLANZAPINE, RISPERIDONE A N D HALOPERIDOL IN ACUTE TREATMENT OF PATIENTS WITH FIRST EPISODE PSYCHOSIS R. Perez,* C. G o n z a l e z - B l a n c h , D. Sierra-Biddle, I. Martfnez, J. L. Vazquez-Barquero, B. Crespo-Facorro
Psychiatry, HospitalMarques de Valdecilla, Santander, Cantabria, Spain The main objetive was to compare the efficacy and safety of two atypical antipsychotics (olanzapine and risperidone) with one another and with a conventional neuroleptic drug (haloperidol) in the acute treatment of"drug-naive psychotic patients at the very early stages of the illness. 44 individuals (26 M, 18 F) with non-affective psychosis in the early stages were randomly assigned to treatment with olanzapine, risperidone or haloperidol for 6-weeks. A naturalistic design
International Congress on Schizophrenia Research 2003
Division of Psychological Medicine, Institute of Psychiatry, King, London, UnitedKingdom (a) The aim of the study was to assess clinical response to clozapine following failure to respond to olanzapine, in patients with schizophrenia or schizoaffective disorder. (b) The study was of a naturalistic design. Individuals who had failed to respond adequately, in the opinion of the responsible clinician, to at least 6 weeks treatment with olanzapine, and who were commencing clozapine as part of their routine clinical management, were the subject group. Standard ratings of clinical state including the Brief Psychiatric Rating Scale (BPRS) were made prior to clozapine initiation and at 6, 12 and 26 weeks of clozapine treatment. A positive response to clozapine was defined a priori as an improvement in BPRS score of at least 20% after 26 weeks treatment with clozapine. (c) 20 subjects were recruited, 13 (65%) completed 26 weeks treatment and 7 (35%) ddropped out of the study. Of the 13 subjects who completed 26 weeks clozapine treatment, 5 (39%) responded to clozapine according to the study criteria of improvement in BPRS score of at least 20%. Of the 7 subjects who dropped out of the study, the main reason was non-compliance with clozapine due to adverse drug effects in 5 (71%) cases. None of the subjects who dropped out of the study improved, according to rating scale scores of clinical response. (d) The conclusion reached from this study is that in a naturalistic setting, failure to respond to olanzapine did not predict failure to respond to clozapine, indicating that despite the similar in vitro pharmacological properties of the two drugs, there are in vivo differences resulting in differing clinical efficacy. This work was supported by a research grant fi'om Novartis Pharmaceuticals UK Ltd
INITIAL TREATMENT OF ACUTELY EXACERBATED AND HIGHLY AGITATED SCHIZOPHRENIC PATIENTS WITH RISPERIDONE E G. Pajonk,* A. Schreiner, S. Peters, E. R u e t h e r
Universitaetsnervenklinik, UniversityHospitals of Saarland, Homburg, Germany Objective: The effectiveness of atypical antipsychotic agents in the treatment of acute schizophrenic episodes is still a subject of" controversial debate. The objective, therefore, was to investigate the efficacy and tolerability of an initial treatment with the atypical antipsychotic agent risperidone in acutely exacerbated patients under the conditions of clinical practice. A sub-analysis was performed to evaluate if highly agitated and aggressive patients may profit from an initial risperidone therapy as well. Material and Methods: In a prospective multicenter observational trial, schizophrenic patients with acute exacerbations tretaed with risperidone within 24 hours of in-patient admission were observed for up to 6 weeks. Patients showing a total score of >15 in the items excitement, hostility and uncooperativeness of the Positive and Negative Syndrome Scale (PANSS) were defined as highly agitated patients. Evaluation of efficacy was carried out according to a modified PANSS, the Clinical Global Impression (CGI) and the Brief Psychiatric Rating Scale (BPRS). Results: 1,625 patients were evaluated. An improvement of all parameters was shown in the whole study group (50% males; age
18. Therapeutics: Treatment Trials 40.5_+15.0 years, paranoid schizophrenia in 67.7% of cases) and in particular in the subgroup of highly agitated patients. In these patients (n=256; 15.7%) a greater improvement in symptoms was observed. Only in 3.7% of patients was risperidone discontinued because of side effects. At the end of the observation, the mean dosage was 4.7 mg/d in the total group and 4.8 mg/d in the highly agitated patients (p=0.54). More than 55% of the patients were finally treated with a risperidone monotherapy. Conclusion: The initial treatment with risperidone proves to be effective and safe even for highly agitated schizophrenic patients under the conditions of clinical practice.
RANDOM-ASSIGNMENT, DOUBLE-BLIND, CLINICAL TRIAL OF ONCE- VERSUS TWICEDAILY ADMINISTRATION OF QUETIAPINE IN PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER H. Parepally,* K. N. Chengappa, J. S. Brar, J. Mullen, A. Schilling, J. M. Goldstein
Psychiatry, WesternPsychiatric, Pittsburgh, PA, USA The purpose of this study was to evaluate the efficacy and safety of administering quetiapine once versus twice daily. Using a doubleblind design, 21 hospitalized patients with schizophrenia (n=7) or schizoaffective disorder (n=14) who had received unchanged dosages (for 2 weeks) of either 400 mg or 600 mg of quetiapine administered twice dally were randomized to once- or twice-daily administration for 4 weeks and then crossed-over to the opposite regimen for an additional 4 weeks. Patients receiving mood stabilizers or antidepressants for schizoaffective disorder remained on those agents. Standard psychopathology and safety measures were used. We found that nearly 70% (15/21) of the patients met a priori efficacy responder criteria with no statistical differences in response between those assigned to a once- or twice-daily dosing schedule. Other statistical analyses confirmed that the majority of patients tolerated the switch to once- or twice-daily administration with quetiapine. A minority experienced worsening of symptoms or orthostatic hypotension during the crossover. Results suggest that it is clinically feasible to switch a majority of quetiapine-treated patients receiving a twicedaily regimen to a once-daily regimen. Quetiapine was generally well tolerated at either dosing schedule. The strategy of administering quetiapine once daily at bedtime may promote improved adherence to treatment.
EFFICACY A N D SAFETY OF OLANZAPINE, RISPERIDONE A N D HALOPERIDOL IN ACUTE TREATMENT OF PATIENTS WITH FIRST EPISODE PSYCHOSIS R. Perez,* C. G o n z a l e z - B l a n c h , D. Sierra-Biddle, I. Martfnez, J. L. Vazquez-Barquero, B. Crespo-Facorro
Psychiatry, HospitalMarques de Valdecilla, Santander, Cantabria, Spain The main objetive was to compare the efficacy and safety of two atypical antipsychotics (olanzapine and risperidone) with one another and with a conventional neuroleptic drug (haloperidol) in the acute treatment of"drug-naive psychotic patients at the very early stages of the illness. 44 individuals (26 M, 18 F) with non-affective psychosis in the early stages were randomly assigned to treatment with olanzapine, risperidone or haloperidol for 6-weeks. A naturalistic design
International Congress on Schizophrenia Research 2003