adult OLZ-treated patients gained more weight (adolescent OLZ:4.3 kg; adult OLZ: 2.2, 3.6, and 3.5 kg and more patients gained≥7% body weight versus placebo. OLZ-treated adolescents andadults experienced significant prolactin increases and reportedtreatment-emergent weight gain and somnolence. Adolescents hadsignificant triglyceride increases (not collected for adults) andadults significant cholesterol increases. No significant elevations inglucose or extrapyramidal symptoms occurred in OLZ-treatedadolescents or adults.

Conclusions: Olanzapine-treated adolescents and adults with schizo-phrenia had significant symptom improvement, but weight, lipid, andprolactin increases were greater in adolescents.

doi:10.1016/j.schres.2007.12.097

31 – OPEN-LABEL TREATMENT WITH OLANZAPINE INADOLESCENTS WITH BIPOLAR MANIA

M. Tohen1,2, L. Kryzhanovskaya 1, G. Carlson3, M. Delbello4,J. Wozniak5, R. Kowatch4, K. Wagner6, R. Findling7, D. Lin1,C. Robertson-Plouch1, W. Xu1, R. Dittmann8,9, J. Biederman5.

1Lilly Research Laboratories, Indianapolis, IN, USA2McLean Hospital, Harvard Medical School, Belmont, MA, USA3Stony Brook University School of Medicine, Stony Brook, NY, USA4University of Cincinnati College of Medicine, Cincinnati, OH, USA5Massachusetts General Hospital, Harvard Medical School, Boston,MA, USA 6University of Texas Medical Branch, Galveston, TX, USA6University of Texas Medical Branch, Galveston, TX, USA7Case Western Reserve University, Cleveland, OH, USA8Lilly Deutschland Medical Department, Bad Homburg, Germany9University of Hamburg, Germany

Presenting Author details: zyp_sci_comm@lilly.comLilly Corporate Center, 46285 Indianapolis, United States,Tel.: +1 317 651 2802; fax: +1 317 433 0448.

Background: More studies of antipsychotic efficacy in adolescentsare needed.

Methods: Adolescents (13–17 years of age) received open-labeltreatment with olanzapine (2.5–20 mg/day) for up to 26 weeksfollowing a double-blind, placebo-controlled phase of up to3 weeks.

Results: A total of 146 patients entered the open-label period andreceived olanzapine (mean daily dose, 10.2 mg/day). YMRS totalscores decreased from baseline (19.2±10.2) to LOCF endpoint(−7.2±12.3, pb .001). The most commonly reported treatment-emergent adverse events were: increased weight, increased appetite,somnolence, sedation and headache. Patients gained 7.5±6.8 kgfrom baseline to endpoint and 69% gained ≥7% of their baselinebody weight. Rates of treatment-emergent abnormal lab valueswere: prolactin (40.5%), ALT/SGPT (22.5%), AST/SGOT (11.6%),creatine phosphokinase (11.6%), creatinine (14.1%), calcium(14.4%), albumin (15.5%), uric acid (21.6%). Rates of statuschange for glucose and lipid levels at any time were: glucose(normal to high, 0.9%); total cholesterol (normal to borderline,13.5%; borderline to high, 20.0%), LDL cholesterol (normal to

borderline, 23.2%; borderline to high, 10.0%), HDL cholesterol(normal to low, 21.5%) and triglycerides (normal to borderline,10.0%; normal to high, 11.3%).

Conclusions: Significant improvement in symptoms of bipolarmania was observed in adolescent patients who received open-labeltreatment with olanzapine. A large proportion of patients experi-enced increases in weight and prolactin and changes in lipidparameters.

doi:10.1016/j.schres.2007.12.098

32 – REMISSION IN SCHIZOPHRENIA ANDPATIENT-RELEVANT OUTCOMES: FINDINGS FROMTHREE STUDIES

M. Kujawa 1, Y. Zhu1, C.V. Damaraju1, R. Risinger1, C. Bossie1.

1Ortho-McNeil Janssen Scientific Affairs, L.L.C., Titusville, USA

Presenting Author details: mkujawamd@aol.com1125 Trenton-Harbourton Road, 08560 Titusville, United States,Tel.: +1 609 730 2442.

Background: Remission criteria in schizophrenia include symptomseverity (absent-to-mild ratings on core symptoms) and duration(≥6 consecutive months). We hypothesized that the durationcomponent is required for improvement in patient-relevantoutcomes.

Methods: Post-hoc analyses of three 1-year studies of schizo-phrenia patients assessed remission status by the Positive andNegative Syndrome Scale. Mutually exclusive populations weredefined: meeting symptom severity and duration criteria (≥6-month remitters); meeting symptom severity but not durationcriteria (severity remitters); never meeting symptom severitycriteria (nonremitters). Measures: Short-Form Health Survey (SF-36) functioning domains (study 1 [N=633]), Strauss CarpenterLevels of Functioning (LOF) and/or Personal and SocialPerformance (PSP) scale (studies 2 [N=316] and 3 [N=235]).Analysis of covariance assessed differences within and betweenpopulations, adjusted by baseline values.

Results: Study 1: ≥6-month remitters improved significantly moreon mean [SE] differences in change scores on SF-36 domains ofsocial functioning, role-emotional and role-physical than severityremitters (13.3 [2.4], 16.6 [3.9] and 9.8 [3.7], respectively) andnonremitters (17.9 [2.4], 16.9 [3.9] and 14.2 [3.7], respectively)(all pb0.01). Severity remitters showed no significant improve-ment vs. nonremitters on SF-36 functioning domains. Study 2:≥6-month remitters, but not severity remitters, improved sig-nificantly more than nonremitters on mean [SE] differences inchange scores on LOF domains quality and quantity of usefulwork (1.3 [0.6]), frequency and quality of social contacts (1.2[0.4]) and fullness of life (0.4 [0.1]) (all pb0.05). Studies 2 and3: ≥6-month remitters and severity remitters improved signifi-cantly more than nonremitters on PSP total score (pb0.05).However, ≥6-month remitters improved significantly more thanseverity remitters (pb0.05).

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

Conclusion: Results suggest remission for≥6 months is important forimprovement in patient-relevant outcomes.

Acknowledgement: Ortho-McNeil Janssen Scientific Affairs, L.L.C.

doi:10.1016/j.schres.2007.12.099

33 – REDUCTION IN SUICIDAL IDEATION, VIOLENTBEHAVIOUR AND SELF-INJURY AFTER TREATMENT WITHRISPERIDONE LONG-ACTING INJECTION

J. Pecenak1, I. Tuma2, M. Povey3, A. Lam 4.

1FNsP Bratislava, Slovakia2FN Hradec Kralove, Czech Republic3SGS Life Science Services, Wavre, Belgium4Johnson and Johnson Pharmaceutical Services, Raritan, NJ, USA

Presenting Author details: alam4@joica.jnj.com19 Green Belt Drive, M3C 1L9 Toronto, Canada,Tel.: +1 416 382 5213.

Background: The high lifetime risk of suicide in schizophrenia iswell established and violent behaviour in schizophrenia is afrequent reason for hospital admission. The objective of thisanalysis is to examine whether the incidence of suicidal ideation,violent behaviour and deliberate self-harm changes in patients withschizophrenia after 12 months of treatment with risperidone long-acting injection (RLAI) who are enrolled in the electronic-Schizophrenia Treatment Adherence Registry (e-STAR) in CzechRepublic and Slovakia.

Methods: e-STAR, a secure web-based, international, prospective,observational study of patients with schizophrenia who have beeninitiated with RLAI. Data are collected both retrospectively(1 year) and prospectively (2 years). Measures for suicidalideation, violent behaviour, and self-injury are collected prospec-tively. In this analysis data from Czech Republic and Slovakiawere pooled.

Results: To date a combined total of 1068 patients have beenenrolled into e-STAR in Czech Republic and Slovakia; 280patients have been followed for at least 12 months (156 CzechRepublic, 124 Slovakia). Of the 280 patients, the majority weremale (57.9%) with a diagnosis of schizophrenia or schizoaffectivedisorder (85.7% and 14.3%, respectively) with a mean age of 37±12.1 years and a mean time since diagnosis of 9.2±9 years.Compared to baseline, significant decreases were seen in theoccurrence of suicidal ideation (18% to 1.1%, pb0.001), violentbehaviour (15.5% to 0.4%, p=0.001) and self-injury (8.6% to0.4%, pb0.001). Individual country results were consistent withthe pooled results.

Conclusions: This interim analysis suggest that patients treated withRLAI for at least 12 months experienced significant decreases in theincidence of suicidal ideation, violent behaviour and self-injury.Follow-up is ongoing until 24 months.

doi:10.1016/j.schres.2007.12.100

34 – CLINICAL AND FUNCTIONAL IMPROVEMENTSIN PATIENTS WITH SCHIZOPHRENIA TREATED WITHRISPERIDONE LONG-ACTING INJECTION: INTERIMRESULTS FROM OBSERVATIONAL STUDIESCONDUCTED IN AUSTRALIA, BELGIUM AND THEUNITED STATES

B. Emmerson1, J. Peuskens2, S. Vallow3, M. Povey4, A. Lam 5.

1Royal Brisbane and Womenʼs Hospital, Australia2Universitair Psychiatrisch Centrum, KU Leuven Campus UC St.Jozef Kortenberg, Belgium3Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ, USA4SGS Biopharma, Wavre, Belgium5Johnson and Johnson Pharmaceutical Services, Raritan, NJ, USA

Presenting Author details: alam4@joica.jnj.com19 Green Belt Drive, M3C 1L9 Toronto, Canada,Tel.: +1 416 382 5213.

Background: To evaluate the 12-month clinical and functionaloutcomes in patients with schizophrenia who received RLAI treatmentand were enrolled in the electronic-Schizophrenia Treatment Adher-ence Registry (e-STAR) in Australia and Belgium and the Schizo-phrenia Outcomes Utilization, Relapse and Clinical Evaluation(SOURCE) in US.

Methods: e-Star and SOURCE are long-term, prospective,observational studies of patients with schizophrenia who com-mence RLAI treatment. Data are collected both retrospectively andprospectively and clinical effectiveness was measured by theClinical Global Impression Severity (CGI-S) scale and patientfunctioning was measured by the Global Assessment of Function-ing (GAF) scale.

Results: Seven hundred and sixty-nine patients (Australia=493,Belgium=163, US=113) with 12 months of follow-up data wereincluded. Australia had significantly younger patients thanBelgium and the US (mean ages: Australia = 38.6, Bel-gium=41.6, US=43.5; p=0.0003). Time since diagnosis (inyears) was significantly higher in the US than Australia andBelgium (US=17.6, Australia=11.6, Belgium=9.8; pb0.0001).US patients had significantly higher baseline GAF scores thanthe Australian and Belgian patients (US=50.9, Australia=42.7,Belgium=43.1; pb0.0001). Despite baseline differences, GAFand CGI-S scores at 12 months for patients treated with RLAIsignificantly improved from baseline in all three countries. CGI-S scores significantly decreased by 0.8 (pb0.001), 1.08(pb0.001) and 0.83 (pb0.001) points and GAF scoressignificantly increased by 12.7 (pb0.001), 14.8 (pb0.001), and11.1 (pb0.001) points in Australia, Belgium, and US,respectively.

Conclusions: This interim analysis from the two observa-tional studies shows that despite differences in patientcharacteristics among countries, treatment with RLAI resultedin significant improvements in disease severity and patientfunctioning in patients with schizophrenia from all threecountries.

doi:10.1016/j.schres.2007.12.101

47ABSTRACTS / Schizophrenia Research 98 (2008) 3–199