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REDUCTION OF FUNCTIONAL DISABILITY WITH ATYPICAL ANTIPSYCHOTIC TREATMENT: A LONG-TERM RANDOMIZED CLINICAL TRIAL
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Abstracts / Schizophrenia Research 102/1–3, Supplement 2 (2008) 1–279
episode psychosis which should be further explored in a head to head comparison. Acknowledgements: This study was funded by Janssen-Cilag. References [1] Schooler, N., J. Rabinowitz, et al. (2005). "Risperidone and Haloperidol in First Episode psychosis: a long-term randomized trial." Am J Psychiatry 162: 947-953.
620 – A 6-WEEK STUDY OF THE EFFICACY AND TOLERABILITY OF ARIPIPRAZOLE IN PEDIATRIC PATIENTS WITH SCHIZOPHRENIA Robert Forbes 1 , Margaretta Nyilas 1 , Na Jin 1 , Randall Owen 2 , Stefan Todorov 3 , William Carson 1 , Christoph Correll 4 1 Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ; 2 Bristol Myers Squibb, Wallingford, CT; 3 Multifunctional Hospital for Active, Varna; 4 Zucker Hillside Hospital, Glen Oaks, NY, USA [email protected] Introduction: Management of adolescents with schizophrenia is limited by the availability of data from double-blind, placebo-controlled trials [1]. Methods: This is a double-blind, placebo-controlled, 6-week study in 302 youths, 13-17 years-old, with a DSM-IV diagnosis of schizophrenia. Patients were randomized 1:1:1 to placebo or a fixed dose of aripiprazole, 10 mg or 30 mg, reached after a 5 or 11 day titration, respectively. The primary endpoint was mean change from baseline on the PANSS Total score at week 6. Secondary endpoints included the PANSS Positive and Negative subscales, CGI-I, and CGAS. Safety measures included incidence of AEs and discontinuation due to AEs. EPS was assessed using the AIMS, SAS, and BARS. Weight change, ECG, and prolactin were measured. Results: 85% of patients completed the study. Both 10 mg and 30 mg arms showed significant differences from placebo on the PANSS Total score at study endpoint, with significant differences observed as early as Week 1 (30mg). Both dose groups showed significant improvement on the PANSS positive, CGI-I scales, CGAS score, and P-QLES-Q Overall score; and the 10 mg dose group was superior to placebo on the PANSS negative score. Most AEs were mild to moderate in severity. The most common AEs were extrapyramidal disorder, somnolence, and tremor. Weight gain and changes in prolactin were minimal. Conclusions: 10mg and 30mg doses of aripiprazole were superior to placebo in the treatment of adolescents with schizophrenia. EPS was the most common adverse event. References [1] American Academy of Child & Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. American Academy of Child and Adolescent Psychiatry. J Am Acad Child Adolesc Psychiatry 2001 Jul;40(7 Su ppl):4S-23S
621 – REDUCTION OF FUNCTIONAL DISABILITY WITH ATYPICAL ANTIPSYCHOTIC TREATMENT: A LONG-TERM RANDOMIZED CLINICAL TRIAL Philip Harvey 1 , Antony Loebel 2 , Charlotte Kremer 2 University School of Medicine, Atlanta, GA; 2 Pfizer, New York, NY, USA [email protected]
1 Emory
Introduction: Recent interest has focused on the definition and measurement of clinical remission in people with schizophrenia and several studies have examined the development of clinical remission during treatment. This study examined the process of development of “functional remission” in a long-term comparative double-blind study of haloperidol and the atypical antipsychotic medication ziprasidone. Methods: Community dwelling patients with schizophrenia were ran-
domized to treatment with haloperidol (n=47) or ziprasidone (n=139). They were re-examined at follow-up intervals that ranged up to 196 weeks. Their community functioning was examined with the Heinrichs-Carpenter Quality of Life Scale (QLS). Scores for employment and social functioning and achievement of improvement milestones across the individual items were analyzed Results: Mixed random-effects models adjusting for length of followup indicated a significant (p<.05) treatment effect favoring ziprasidone for social functioning. While the mixed model was not significant for employment, the 95% confidence interval for change scores in the haloperidol group overlapped with 0, while mean change was significantly greater than 0 for the ziprasidone group. Analyses of the distributions of change scores across the items showed that the number of items where endpoint scores were 5 or 6 (reflecting minimal to no impairment) was significantly higher in ziprasidone treated patients, (X2 [8]=16.92, p=.03). Conclusions: Long term treatment with ziprasidone was associated with greater functional gains than treatment with haloperidol, even when differential dropout was controlled. Acknowledgements: Funded by Pfizer, Inc References [1] Bowie CR, Reichenberg A, Patterson TL, Heaton RK, Harvey PD: Determinants of real world functional performance in schizophrenia subjects: Correlations with cognition, functional capacity, and symptoms. American Journal of Psychiatry 2006; 163:418-425 [2] Bellack AS, Green MF, Cook JA, Fenton W, Harvey PD, Heaton RK, Laughren T, Leon AC, Mayo D, Patrick DL, Patterson TL, Rose A, Stover E, Wykes T: Assessment of community functioning in people with schizophrenia and other severe mental illnesses: A white paper based on an NIMH-sponsored workshop. Schizophrenia Bulletin 2007; 33:805-822
622 – COMPARISON OF RISPERIDONE ORODISPERSIBLE TABLET AND INTRAMUSCULAR HALOPERIDOL IN TREATMENT OF ACUTE PSYCHOTIC AGITATION: A PROSPECTIVE AND RANDOMIZED STUDY Jung Jin Kim, Hyun Kook Lim, Chang Uk Lee, Chul Lee, Chi Un Pae, In Ho Paik The Catholic University of Korea, Seoul, Korea [email protected] Introduction: Psychotic agitation characterized by psychotic symptoms, anxiety, hostility, and uncontrolled or violent behavior is often manifested by patients with psychiatric diseases. It is needed to relieve psychotic agitation rapidly for the patients in emergency room or inpatient ward. Common and traditional treatment for psychotic agitation consists of parenteral or intramuscular administration of antipsychotics or benzodiazepines. Haloperidol, high-potency and typical antipsychotics, is frequently used for psychotic agitation due to a potency of rapid tranquilization and relatively low risk of side effects. However, parenteral or intramuscular administration of haloperidol has a risk of accidental needle stick injury associated with infection for both patients and staff. As risperidone orodispersible tablet is quickly absorbed in an oral cavity of a patient within a few seconds, it could be used for the patients with psychotic agitation. In this study, comparison of the efficacy and safety of oral risperidone and intramuscular haloperidol was performed in emergency treatment of psychotic agitation by prospective, randomized, and rater-blinded way. Methods: One hundred and forty four patients with psychotic agitation were recruited at emergency room or inpatient ward at Catholic University of Korea, Kangnam St. Mary’s hospital, Seoul, South Korea. They were diagnosed as schizophrenia or schizoaffective disorder, bipolar I disorder with or without psychotic features, delusional disorders, or psychotic disorder, NOS by DSM-IV. All the patients enrolled in this study provided written informed consent before taking medication and randomly assigned to either group of risperidone orodispersible tablet or intramuscular haloperidol. Efficacy of both treatments were measured and compared by the scores of 5-item
Abstracts / Schizophrenia Research 102/1–3, Supplement 2 (2008) 1–279
episode psychosis which should be further explored in a head to head comparison. Acknowledgements: This study was funded by Janssen-Cilag. References [1] Schooler, N., J. Rabinowitz, et al. (2005). "Risperidone and Haloperidol in First Episode psychosis: a long-term randomized trial." Am J Psychiatry 162: 947-953.
620 – A 6-WEEK STUDY OF THE EFFICACY AND TOLERABILITY OF ARIPIPRAZOLE IN PEDIATRIC PATIENTS WITH SCHIZOPHRENIA Robert Forbes 1 , Margaretta Nyilas 1 , Na Jin 1 , Randall Owen 2 , Stefan Todorov 3 , William Carson 1 , Christoph Correll 4 1 Otsuka Pharmaceutical Development & Commercialization, Princeton, NJ; 2 Bristol Myers Squibb, Wallingford, CT; 3 Multifunctional Hospital for Active, Varna; 4 Zucker Hillside Hospital, Glen Oaks, NY, USA [email protected] Introduction: Management of adolescents with schizophrenia is limited by the availability of data from double-blind, placebo-controlled trials [1]. Methods: This is a double-blind, placebo-controlled, 6-week study in 302 youths, 13-17 years-old, with a DSM-IV diagnosis of schizophrenia. Patients were randomized 1:1:1 to placebo or a fixed dose of aripiprazole, 10 mg or 30 mg, reached after a 5 or 11 day titration, respectively. The primary endpoint was mean change from baseline on the PANSS Total score at week 6. Secondary endpoints included the PANSS Positive and Negative subscales, CGI-I, and CGAS. Safety measures included incidence of AEs and discontinuation due to AEs. EPS was assessed using the AIMS, SAS, and BARS. Weight change, ECG, and prolactin were measured. Results: 85% of patients completed the study. Both 10 mg and 30 mg arms showed significant differences from placebo on the PANSS Total score at study endpoint, with significant differences observed as early as Week 1 (30mg). Both dose groups showed significant improvement on the PANSS positive, CGI-I scales, CGAS score, and P-QLES-Q Overall score; and the 10 mg dose group was superior to placebo on the PANSS negative score. Most AEs were mild to moderate in severity. The most common AEs were extrapyramidal disorder, somnolence, and tremor. Weight gain and changes in prolactin were minimal. Conclusions: 10mg and 30mg doses of aripiprazole were superior to placebo in the treatment of adolescents with schizophrenia. EPS was the most common adverse event. References [1] American Academy of Child & Adolescent Psychiatry. Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. American Academy of Child and Adolescent Psychiatry. J Am Acad Child Adolesc Psychiatry 2001 Jul;40(7 Su ppl):4S-23S
621 – REDUCTION OF FUNCTIONAL DISABILITY WITH ATYPICAL ANTIPSYCHOTIC TREATMENT: A LONG-TERM RANDOMIZED CLINICAL TRIAL Philip Harvey 1 , Antony Loebel 2 , Charlotte Kremer 2 University School of Medicine, Atlanta, GA; 2 Pfizer, New York, NY, USA [email protected]
1 Emory
Introduction: Recent interest has focused on the definition and measurement of clinical remission in people with schizophrenia and several studies have examined the development of clinical remission during treatment. This study examined the process of development of “functional remission” in a long-term comparative double-blind study of haloperidol and the atypical antipsychotic medication ziprasidone. Methods: Community dwelling patients with schizophrenia were ran-
domized to treatment with haloperidol (n=47) or ziprasidone (n=139). They were re-examined at follow-up intervals that ranged up to 196 weeks. Their community functioning was examined with the Heinrichs-Carpenter Quality of Life Scale (QLS). Scores for employment and social functioning and achievement of improvement milestones across the individual items were analyzed Results: Mixed random-effects models adjusting for length of followup indicated a significant (p<.05) treatment effect favoring ziprasidone for social functioning. While the mixed model was not significant for employment, the 95% confidence interval for change scores in the haloperidol group overlapped with 0, while mean change was significantly greater than 0 for the ziprasidone group. Analyses of the distributions of change scores across the items showed that the number of items where endpoint scores were 5 or 6 (reflecting minimal to no impairment) was significantly higher in ziprasidone treated patients, (X2 [8]=16.92, p=.03). Conclusions: Long term treatment with ziprasidone was associated with greater functional gains than treatment with haloperidol, even when differential dropout was controlled. Acknowledgements: Funded by Pfizer, Inc References [1] Bowie CR, Reichenberg A, Patterson TL, Heaton RK, Harvey PD: Determinants of real world functional performance in schizophrenia subjects: Correlations with cognition, functional capacity, and symptoms. American Journal of Psychiatry 2006; 163:418-425 [2] Bellack AS, Green MF, Cook JA, Fenton W, Harvey PD, Heaton RK, Laughren T, Leon AC, Mayo D, Patrick DL, Patterson TL, Rose A, Stover E, Wykes T: Assessment of community functioning in people with schizophrenia and other severe mental illnesses: A white paper based on an NIMH-sponsored workshop. Schizophrenia Bulletin 2007; 33:805-822
622 – COMPARISON OF RISPERIDONE ORODISPERSIBLE TABLET AND INTRAMUSCULAR HALOPERIDOL IN TREATMENT OF ACUTE PSYCHOTIC AGITATION: A PROSPECTIVE AND RANDOMIZED STUDY Jung Jin Kim, Hyun Kook Lim, Chang Uk Lee, Chul Lee, Chi Un Pae, In Ho Paik The Catholic University of Korea, Seoul, Korea [email protected] Introduction: Psychotic agitation characterized by psychotic symptoms, anxiety, hostility, and uncontrolled or violent behavior is often manifested by patients with psychiatric diseases. It is needed to relieve psychotic agitation rapidly for the patients in emergency room or inpatient ward. Common and traditional treatment for psychotic agitation consists of parenteral or intramuscular administration of antipsychotics or benzodiazepines. Haloperidol, high-potency and typical antipsychotics, is frequently used for psychotic agitation due to a potency of rapid tranquilization and relatively low risk of side effects. However, parenteral or intramuscular administration of haloperidol has a risk of accidental needle stick injury associated with infection for both patients and staff. As risperidone orodispersible tablet is quickly absorbed in an oral cavity of a patient within a few seconds, it could be used for the patients with psychotic agitation. In this study, comparison of the efficacy and safety of oral risperidone and intramuscular haloperidol was performed in emergency treatment of psychotic agitation by prospective, randomized, and rater-blinded way. Methods: One hundred and forty four patients with psychotic agitation were recruited at emergency room or inpatient ward at Catholic University of Korea, Kangnam St. Mary’s hospital, Seoul, South Korea. They were diagnosed as schizophrenia or schizoaffective disorder, bipolar I disorder with or without psychotic features, delusional disorders, or psychotic disorder, NOS by DSM-IV. All the patients enrolled in this study provided written informed consent before taking medication and randomly assigned to either group of risperidone orodispersible tablet or intramuscular haloperidol. Efficacy of both treatments were measured and compared by the scores of 5-item