308 – ANTIPSYCHOTIC MEDICATION USAGE PATTERNSIN AUSTRALIA TO TREAT PATIENTS WITHSCHIZOPHRENIA

A.R. De Castella1, A. Nicol1, P.B. Fitzgerald1, J. Kulkarni1.

1Alfred Psychiatry Research Centre, The Alfred and MonashUniversity, School of Psychology, Psychiatry and PsychologicalMedicine, Melbourne, Australia

Presenting Author details: a.decastella@alfred.org.auPO Box 315, Level 1 –Old Baker Building, The Alfred, 3181 Prahran,Australia,Tel.: +61 3 9076 6554; fax: +61 3 9076 6588.

Background: The availability of six different “atypical” Antipsycho-tic Medications (AM's), in addition to a large number of “typical”AM's, provides clinicians with a range of treatment options, whichshould enhance outcomes for patients with schizophrenia. Choosingwhich medication or combination of medications is best for eachpatient can be a process of trial and error, resulting in polypharmacyand multiple switching of medications over time. The aim of the studyis to improve our understanding of how AM's are being used in the‘real world’ in an Australian cohort of people with schizophrenia overa 12-month period.Methods: Medical records of 125 patients with schizophrenia orschizoaffective disorder were reviewed over a 12-month periodfollowing a hospitalization. Information was extracted in relation toall pharmacotherapy treatments received.Results: Mean age of the sample was 37.7 years and the majoritywere male (86/39). 80% had a diagnosis of schizophrenia while 20%had schizoaffective disorder. 37 patients (30%) were receivingmultiple AM's at discharge from hospital. 101 of the 125 patients(81%) received more than one antipsychotic medication over the 12-month period, with an average of 2.7 different AM's per patient. Themean time to switching of primary AM's after discharge was157 days. The most commonly prescribed AM's at discharge wereClozapine (33), Olanzapine (29), Zuclopenthixol Depot (27) andRisperidone (13).Conclusions: Most patients with schizophrenia/schizoaffective disorderhave multiple changes made to their treatment regime over a 1-yearperiod, suggesting that the current range of AM's on the market is notsufficient to adequately treat these illnesses. Future research is needed toevaluate which combinations of AM's, at which doses, in whichsubgroups of patients result in themost optimal outcomes for people withschizophrenia.Acknowledgement: Funding provided by Janssen-Cilag Australia.

doi:10.1016/j.schres.2007.12.375

309 – AN OPEN-LABEL TRIAL OF RISPERIDONELONG-ACTING INJECTABLE

R. Emsley1, R. Medori2, L. Koen1, P. Oosthuizen1, J. Rabinowitz3.

1Department of Psychiatry, University of Stellenbosch, Cape Town,South Africa2Janssen-Cilag EMEA, Beerse, Belgium3Bar Ilan University, Israel

Presenting Author details: rae@sun.ac.zaDepartment of Psychiatry, Faculty of Health Sciences, PO Box 19063,Tygerberg, 7500 Cape Town, South Africa,Tel.: +27 21 9389227; fax: +27 21 9336159.

Background: First generation depot antipsychotics simplified admin-istration, improved compliance and reduced relapse. Second generationantipsychotics have a better safety and efficacy profile than firstgeneration antipsychotics. Risperidone long acting injection (RLAI) isthe first injectable second generation antipsychotic. We examined its usein recent onset psychosis.Methods: This was a 24-month open-label non-randomized, singlearm, single center study of 50 adults with newly diagnosedschizophrenia or schizophreniform disorder. Oro-dispersible risper-idone was given through day 21 at a dose of 1 to 3 mg/d. At day 7 thefirst injection of 25 mg RLAI was given and subsequent injectionswere given every 2 weeks.Results: 72% of patients (n=37) completed the full 24-month trial.Final RLAI dose for 54% of patients was 25 mg, for 30% 37.5 mg andfor 16% 50 mg. There was significant improvement from baseline toendpoint on the mean PANSS total (−39.7±21.1, from baseline 90.3±13.8, pb .0001), positive subscale (−15.3±6.7, from baseline 25.1±4.0, pb .0001), negative subscale (−7.6± 7.5, from baseline 24.5±8.5, pb .0001) and general psychopathology subscale (−16.7±10.1,from baseline 40.7±6.2, pb .0001). 64% (n=32) of patients remittedduring the trial (maintained for at least 6 months a “mild” or lowerlevel on 8 key PANSS items). Adverse events (AE's) observed in atleast 10% of patients were: blood prolactin increased, headache,sedation, influenza, parkinsonism, extrapyramidal disorder, aggres-sion, insomnia, depression, blood cholesterol increased, psychoticdisorder. Two patients suffered serious AE's (cerebrovascularaccident and psychotic disorder) that resulted in discontinuationfrom study. At endpoint mean BMI gain was 4.8±3.8 from 20.6±4.6at baseline (pb .001).Conclusions: This study allows only for some tentative conclusions.Patients showed good symptom improvement, a favorable adverseevent profile and high compliance. Safety and efficacy in thispopulation warrants further investigation in a controlled manner.

doi:10.1016/j.schres.2007.12.376

310 – COMPARATIVE MORTALITY ASSOCIATED WITHZIPRASIDONE VS. OLANZAPINE IN REAL-WORLD USE: THEZIPRASIDONE OBSERVATIONAL STUDY OF CARDIACOUTCOMES (ZODIAC)

B. Strom1, G. Faich2, S. Eng3, R. Reynolds3, R. D'Agostino Sr4,J. Ruskin5, J. Kane6.

1Department of Biostatistics and Epidemiology, University ofPennsylvania, Philadelphia, PA, USA2Department of Epidemiology, United BioSource Corporation, BlueBell, PA, USA3Pfizer Inc, New York, NY, USA4Boston University Mathematics and Statistics Department, Boston,MA, USA5Massachusetts General Hospital, Boston, MA, USA6Department of Psychiatry, Zucker Hillside Hospital, Glen Oaks, NY,USA

160 ABSTRACTS / Schizophrenia Research 98 (2008) 3–199

Presenting Author details: sybil.eng@pfizer.com235 East 42nd Street, 10017 New York, United States,Tel.: +1 212 7333316; fax: +1 212 8088679.

Background: Whether the modest QTc-prolonging effect of ziprasi-done increases cardiovascular event risk is unknown. This large simpletrial compared the risk of nonsuicide death associated with ziprasidonevs. olanzapine in real-world use.Methods: The Ziprasidone Observational Study of Cardiac Outcomes(ZODIAC), an open-label, randomized, post marketing study, enrolledpatients with schizophrenia from routine clinical practice settings in 18countries. A total of 18,154 subjects were randomized to eitherziprasidone or olanzapine, dosed according to the enrolling physician'sclinical judgment. The primary outcome was non-suicide mortalityduring the year after treatment initiation. A physician-administeredbaseline questionnaire collected information on demographics,medical and psychiatric history and concomitant medication use.Brief follow-up questionnaires elicited data on incidence of patienthospitalization since the last study visit, vital status, study medicationcontinuation and concomitant antipsychotic medication(s) use.Results: ZODIAC study subjects reflected the general population ofpatients with schizophrenia. The incidence of nonsuicide mortalitywithin 1 year of initiating therapy was 0.91% for the ziprasidone groupcompared with 0.90% for the olanzapine group (both n=9077), yieldinga relative risk (95% confidence interval [CI]) of 1.01 (0.75, 1.37). Thisfinding was robust in numerous secondary and sensitivity analyses.Regarding secondary endpoints, the risk of all-cause mortality orcardiovascular mortality was similar among ziprasidone and olanzapineusers whereas the incidence of all cause hospitalizations was higheramong those randomized to ziprasidone. The proportion of patients whoremained on treatment at 6 months was significantly lower for theziprasidone group compared with the olanzapine group (proportion(95% CI)=64.6% (63.6, 65.6) and 73.2% (72.3, 74.1), respectively).Conclusions: ZODIAC is the largest randomized studies of patientswith schizophrenia conducted to date. With substantial statisticalpower, the study did not detect an increased risk of nonsuicide deathassociated with the use of ziprasidone vs. olanzapine.

doi:10.1016/j.schres.2007.12.377

311 – EFFECTS OF ATYPICAL ANTIPSYCHOTICS ON LEPTINAND GHRELIN

A. Esen-Danaci1, A. Sarandol2, F. Taneli3, N. Ozlen3.

1Celal Bayar University Medical School, Department of Psychiatry,Turkey2Uludag University Medical School, Department of Psychiatry,Turkey3Celal Bayar University Medical School, Department of Biochemistry,Turkey

Presenting Author details: aedanaci@yahoo.comCelal Baya University Medical School Department of Psychiatry,45010 Manisa, Turkey,Tel.: +90 236 2350357; fax: +90 236 2350357.

Background: Weight-gain is a major side effect of atypical antipsycho-tics. Bodyweight is regulated by a complex system. Two of the hormones

that seem to play an important role in the regulation of food intake, energymetabolism and body weight are leptin and ghrelin. Leptin is a mediatorof long-term regulation of energy balance, suppressing food intake andthereby inducing weight loss. Ghrelin on the other hand is a fast-actinghormone, seemingly playing a role in meal initiation. In this study it isaimed to compare the effects of five different atypical antipsychoticmedications on leptin and ghrelin.Methods: One hundred and twelve (112) patients who were treatedeither with clozapine (n=20), olanzapine (n=28), risperidone (n=22),quetiapine (n=20) or amisupride (n=22) for at least 1 year and healthycontrol group (n=23) were assessed cross-sectionally. Ghrelin andleptin levels were measured with enzyme immunoassay.Results:When fasting serum leptin levels were compared, control grouphad the highest mean value (9.2±6.7) and amisulpride group had thelowest mean value (3.7±2.1) but still there was no statistically significantdifference between six groups (F=1993, p=0.084). In the comparison ofthe mean values of fasting serum ghrelin levels there was a statisticallysignificant difference between groups (F=11,473, p=0.00). In post-hocanalysis it was seen that the control group had the lowest ghrelin level(194.5±86.8). Quetiapine treated group (378.1±260.4) had similarghrelin levels to control group. All the other antipsychotic treatmentgroups had significantly higher levels of ghrelin compared to controlgroup, highest in amisulpride treated group (597.0±150.0).Conclusions: The weight-gain side effect of atypical antipsychoticscan be related with the orexigen effect of elevated serum ghrelin ratherthan leptin deficit. Among the five widely used atypical antipsychoticsquetiapine is the only one which does not elevate the ghreline level.

doi:10.1016/j.schres.2007.12.378

312 – COMPARATIVE STUDY OF QING XIN CHONG JI-I HAOIN TREATMENT OF SCHIZOPHRENIA

B. Han1, R. Tang2, H. Sun1, P. Bai1.

1Department of Psychiatry, Shanxi Medical University2Department of Neurology, Tongji Medical College, HuazhongScience and Technology University

Presenting Author details: hanbai99@hotmail.comXin Jian South Road 86, 030001 Taiyuan City, China,Tel.: +86 351 8604188; fax: +86 351 4690865.

Background: To evaluate the therapeutic of the self-dispense herbformula – Qing Xin Chong Ji-I Hao combined risperidone on theschizophrenia in the treatment of schizophrenia and to observe QingXin Chong Ji-I Hao effect on reducing side effects of antipsychotics.Methods: All the subjects were diagnosed as schizophrenia accordingto the DSM-IV-R diagnosis standard and were randomized into 4groups: the treatment group 1 (Qing Xin Ji-I Hao combined withrisperidone or olanzapine) and the control group1 without Qing Xin Ji-I Hao; the treatment group 2 (Qing Xin Ji-I Hao combined withsulpiride or clozapine) and the control group 2 without Qing XinChong Ji-I Hao; The treatment lasted for 8 weeks. The patients' bloodroutine, urine routine, blood sugar, blood urea nitrogen, liver function,electrocardiogram, electroencephalogram were tested before and at the2nd, 4th, 6th, 8th weeks after the treatment. The Positive and NegativeSyndrome Scale (PANSS) were used to evaluate therapeutic effects,and Treatment Emergent Side effect Scale (TESS) was used to estimate

161ABSTRACTS / Schizophrenia Research 98 (2008) 3–199