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Olanzapine versus haloperidol in the treatment of first episode psychosis
151
accompanied by an improvement in cognitive dysfunction and can also positively impact a patient's quality of life and resource utilization. In this multicentre, randomized, double-blind, parallel study, 65 stable patients in the first five years of illness were randomized to one of three treatment groups: olanzapine in the dose range of 5 mg to 20 mg per day, risperidone in the dose range of 4mg to 10mg per day, or haloperidol in the dose range of 5 mg to 20 mg per day. Patients were excluded from the trial if they exhibited baseline PANSS>90. After a one-month stabilization period and a one-week washout/screening period, patients were randomized and followed on therapy for 54 weeks. Dosing after the first week of therapy was carried out on a per patient basis and at the judgement of the attending physician. Results comparing olanzapine to risperidone and olanzapine to haloperidol for efficacy (neuropsychological exams, PANSS), safety (ESR5;, Barnes Akathisia), quality of life (QLS, SF-36), and resource utilization are presented. Tests of the primary measures are performed both for endpoint values and change-from-baseline at endpoint. In this select population, olanzapine shows marked benefits on cognition, especially, compared with risperidone and haloperidol.
OLANZAPINE VERSUS HALOPERIDOL THE TREATMENT OF FIRST EPISODE PSYCHOSIS
IN
T.M. Sanger, J.A. Lieberman, M. Tohen, G.D. Tollefson
Lilly Research Laboratories, Lilly Corporate ('enter. Indianapolis, IN 46285, USA These analyses explore the effect of olanzapine versus haloperidol in the treatment of first episode psychosis in an international, multicenter, double-blind, parallel trial. This trial compared the efficacy and safety of a single dose range of olanzapine, 5 -20 mg/day, to a single dose range of haloperidol, 5 21)mg/day, in the treatment of 1996 in- and out-patients with a DSM-III-R diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder. Patients were assigned by random allocation to double-blind therapy in the ratio of 2 olanzapine to 1 haloperidol assignment. The acute phase of the trial was 6 weeks in length which was followed by a double-blind responder extension and a open-label nonresponder extension. Of the 1996 patients enrolled in the trial, 83 (59 olanzapine, 24 haloperidol) were in their first episode of psychosis with an episode duration of _<5 years and age at onset of _<45 years. In this subgroup of first episode patients, olanzapine was statistically significantly superior to haloperidol in the reduction of BPRS total score, BPRS negative score, PANSS total score, and PANSS positive score from baseline to endpoint of the acute phase (last-observation-carriedforward ). Also, haloperidol first episode patients suffered statistically significantly more EPS and akathisia than olanzapine first episode patients as measured by changes in SimpsonAngus total and Barnes global item from baseline to endpoint of the acute therapy.
OLANZAPINE IN THE TREATMENT SCHIZOAFFECTIVE DISORDER
OF
P. Tran, Y. Lu, T. Sanger, C. Beasley, G. Tollefson
Eli Lilly and Company, Lilly Corporate Center. Indianapolis, Indiana 46285. USA Study HGAJ was an international, multicenter, double-blind trial which compared the efficacy and safety of a single doserange of olanzapine ( 5--20 rag) to a single dose-range of haloperidol (5-20rag) in the treatment of 1996 patients with a DSM I II-R diagnosis of schizophrenia, schizophreniform disorder and schizoaffective disorder. During the acute phase (6 weeks), a total of 300 patients with schizoaffective disorder were enrolled ( 177 schizoaffective, bipolar type and 123 schizoaffective, depressive type). The efficacy data on this subset of patients with scbizoaffective disorder will be presented in this poster. Overall, the olanzapine-treated patients with schizoaffective disorder and the subgroup of patients with schizoaffective disorder, bipolar type experienced statistically significantly greater improvement on mean change from baseline to endpoint in BPRS total, PANSS total, PANSS negative, CGI severity and MADRS total scores when compared with the haloperidol treatment group. For the subgroup of patients with the diagnosis of schizoaffective, depressed type, the mean improvement in the olanzapine-treated patients was only marginally statistically significantly greater than that in the haloperidol-treated patients, however the magnitude of the differences in BPRS total, PANSS total, and PANSS negative scores was greater than that observed in the subgroup of patients with schizoaffective, bipolar type. We conclude that olanzapine is significantly superior to haloperidol in the treatment of patients suffering from schizoaffective disorder.
OLANZAPINE IN THE TREATMENT ELDERLY PATIENTS WITH SCHIZOPHRENIA AND RELATED PSYCHOTIC DISORDERS
OF
S.G. Reams, T.M. Sanger, C.M. Beasley Jr.
Eli Lilly and Company, Indianapolis, Lilly Corporate Center Indiana 46285. USA Elderly psychotic patients are particularly sensitive to the adverse effects associated with conventional antipsychotic therapies. Atypical antipsychotics, such as olanzapine, may offer significant therapeutic advantages. In a 6-week double-blind trial in patients meeting diagnostic criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder, 59 patients, aged 65 years or older, were randomized to treatment with olanzapine (5 20 rag/day) or haloperidol (5 20 mg/day). Olanzapine-treated patients had greater improvement in BPRS total, PANSS total and negative, and MADRS total scores, although the difference did not reach statistical significance. Treatment-emergent adverse events commonly reported (_> 10% incidence) by olanzapine-treated patients included insomnia, somnolence, and accidental injury. The incidence rates were
accompanied by an improvement in cognitive dysfunction and can also positively impact a patient's quality of life and resource utilization. In this multicentre, randomized, double-blind, parallel study, 65 stable patients in the first five years of illness were randomized to one of three treatment groups: olanzapine in the dose range of 5 mg to 20 mg per day, risperidone in the dose range of 4mg to 10mg per day, or haloperidol in the dose range of 5 mg to 20 mg per day. Patients were excluded from the trial if they exhibited baseline PANSS>90. After a one-month stabilization period and a one-week washout/screening period, patients were randomized and followed on therapy for 54 weeks. Dosing after the first week of therapy was carried out on a per patient basis and at the judgement of the attending physician. Results comparing olanzapine to risperidone and olanzapine to haloperidol for efficacy (neuropsychological exams, PANSS), safety (ESR5;, Barnes Akathisia), quality of life (QLS, SF-36), and resource utilization are presented. Tests of the primary measures are performed both for endpoint values and change-from-baseline at endpoint. In this select population, olanzapine shows marked benefits on cognition, especially, compared with risperidone and haloperidol.
OLANZAPINE VERSUS HALOPERIDOL THE TREATMENT OF FIRST EPISODE PSYCHOSIS
IN
T.M. Sanger, J.A. Lieberman, M. Tohen, G.D. Tollefson
Lilly Research Laboratories, Lilly Corporate ('enter. Indianapolis, IN 46285, USA These analyses explore the effect of olanzapine versus haloperidol in the treatment of first episode psychosis in an international, multicenter, double-blind, parallel trial. This trial compared the efficacy and safety of a single dose range of olanzapine, 5 -20 mg/day, to a single dose range of haloperidol, 5 21)mg/day, in the treatment of 1996 in- and out-patients with a DSM-III-R diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder. Patients were assigned by random allocation to double-blind therapy in the ratio of 2 olanzapine to 1 haloperidol assignment. The acute phase of the trial was 6 weeks in length which was followed by a double-blind responder extension and a open-label nonresponder extension. Of the 1996 patients enrolled in the trial, 83 (59 olanzapine, 24 haloperidol) were in their first episode of psychosis with an episode duration of _<5 years and age at onset of _<45 years. In this subgroup of first episode patients, olanzapine was statistically significantly superior to haloperidol in the reduction of BPRS total score, BPRS negative score, PANSS total score, and PANSS positive score from baseline to endpoint of the acute phase (last-observation-carriedforward ). Also, haloperidol first episode patients suffered statistically significantly more EPS and akathisia than olanzapine first episode patients as measured by changes in SimpsonAngus total and Barnes global item from baseline to endpoint of the acute therapy.
OLANZAPINE IN THE TREATMENT SCHIZOAFFECTIVE DISORDER
OF
P. Tran, Y. Lu, T. Sanger, C. Beasley, G. Tollefson
Eli Lilly and Company, Lilly Corporate Center. Indianapolis, Indiana 46285. USA Study HGAJ was an international, multicenter, double-blind trial which compared the efficacy and safety of a single doserange of olanzapine ( 5--20 rag) to a single dose-range of haloperidol (5-20rag) in the treatment of 1996 patients with a DSM I II-R diagnosis of schizophrenia, schizophreniform disorder and schizoaffective disorder. During the acute phase (6 weeks), a total of 300 patients with schizoaffective disorder were enrolled ( 177 schizoaffective, bipolar type and 123 schizoaffective, depressive type). The efficacy data on this subset of patients with scbizoaffective disorder will be presented in this poster. Overall, the olanzapine-treated patients with schizoaffective disorder and the subgroup of patients with schizoaffective disorder, bipolar type experienced statistically significantly greater improvement on mean change from baseline to endpoint in BPRS total, PANSS total, PANSS negative, CGI severity and MADRS total scores when compared with the haloperidol treatment group. For the subgroup of patients with the diagnosis of schizoaffective, depressed type, the mean improvement in the olanzapine-treated patients was only marginally statistically significantly greater than that in the haloperidol-treated patients, however the magnitude of the differences in BPRS total, PANSS total, and PANSS negative scores was greater than that observed in the subgroup of patients with schizoaffective, bipolar type. We conclude that olanzapine is significantly superior to haloperidol in the treatment of patients suffering from schizoaffective disorder.
OLANZAPINE IN THE TREATMENT ELDERLY PATIENTS WITH SCHIZOPHRENIA AND RELATED PSYCHOTIC DISORDERS
OF
S.G. Reams, T.M. Sanger, C.M. Beasley Jr.
Eli Lilly and Company, Indianapolis, Lilly Corporate Center Indiana 46285. USA Elderly psychotic patients are particularly sensitive to the adverse effects associated with conventional antipsychotic therapies. Atypical antipsychotics, such as olanzapine, may offer significant therapeutic advantages. In a 6-week double-blind trial in patients meeting diagnostic criteria for schizophrenia, schizophreniform disorder, or schizoaffective disorder, 59 patients, aged 65 years or older, were randomized to treatment with olanzapine (5 20 rag/day) or haloperidol (5 20 mg/day). Olanzapine-treated patients had greater improvement in BPRS total, PANSS total and negative, and MADRS total scores, although the difference did not reach statistical significance. Treatment-emergent adverse events commonly reported (_> 10% incidence) by olanzapine-treated patients included insomnia, somnolence, and accidental injury. The incidence rates were