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FACTORIAL ANALYSIS OF PSYCHOTIC LIKE EXPERIENCES AND HELP SEEKING BEHAVIOUR IN A COMMUNITY SAMPLE OF YOUNG ADULTS
184
Abstracts
ziprasidone, n = 8 for olanzapine). The sensitivity analysis incorporating unattended or ill-defined causes of death (R98 and R99) yielded a similar result (RR = 0.73, 95% CI: 0.44, 1.22). Further, the supplemental sensitivity analysis resulted in a risk ratio of 0.99 (95% CI: 0.65, 1.50). Discussion: ZODIAC is the largest randomized study of patients with schizophrenia conducted to date. With substantial statistical power, the study did not detect an increased risk of non-suicide death associated with the use of ziprasidone vs. olanzapine. Post hoc readjudication analyses of mortality events supported the initial findings that there is no increased risk of sudden death comparing persons randomized to ziprasidone vs. olanzapine across all endpoints. doi:10.1016/j.schres.2010.02.227
POSTER SESSION 1 & LUNCH Sunday, 11 April, 2010 -12:00 pm -1:30 pm Poster 1 FACTORIAL ANALYSIS OF PSYCHOTIC LIKE EXPERIENCES AND HELP SEEKING BEHAVIOUR IN A COMMUNITY SAMPLE OF YOUNG ADULTS Marco Armando1,2,4,5, Saba Riccardo1, Righetti Valentino1, Dario Claudia1, Monducci Elena1,4, Girardi Paolo4, Nelson Barnaby3, Yung Alison3, Birchwood Maximilian2, Fiori Nastro Paolo1 1 PhD School “Early Intervention in Psychosis” “Sapienza” University Department of Psychiatry Rome, Italy, Italy; 2School of Psychology University of Birmingham Birmingham, UK, United Kingdom; 3Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne Victoria, Australia, Australia; 4PhD School “Early Intervention in Psychosis”, Sant' Andrea Hospital and “Sapienza” University of Rome NESMOS Department Rome, Italy, Italy; 5Department of Mental Health, Azienda Unità Sanitaria Locale di Viterbo Viterbo, Italy, Italy Background: Studies conducted in community samples suggest that psychotic-like experiences (PLEs) are common in the general population, leading to suggestions that they are either variations of normal personality or different expressions of vulnerability to psychotic disorder. This study aimed to determine if different subtypes of PLEs could be identified in a community sample of young adults and to investigate if particular subtypes were more likely to be associated with 4 poor mental health markers: psychosocial distress, depression, poor functioning and help-seeking. Methods: 997 students from two different italian universities participated in a cross-sectional multisite survey that measured PLEs using the Positive Scale of the Community Assessment of Psychic Experiences (CAPE), depression and distress using the Depression Scale and the Distress Scale of the CAPE, and functioning using the General Health Questionnaire-12 (GHQ-12). Factor analysis was conducted to identify any subtypes of PLEs. Results: Four subtypes of PLES were identified: Bizarre Experiences (BE), Perceptual Abnormalities (PA), Persecutory Ideas (PI), and Magical Thinking (MT). Intermittent, infrequent psychotic experiences were common, but frequent experiences were not. Only PI were strongly associated with all of the poor mental health markers. Discussion: Different subtypes of PLEs can be identified in this large sample, confirming the findings of our previous studies. This subtypes seem to be maladaptive in different ways and may therefore index different levels of risk of developing psychiatric disorders, compared to PLEs defined as an homogenous entity. doi:10.1016/j.schres.2010.02.229
Poster 2 EXAMINING PATIENT VALIDITY FOR CLINICAL: A POST-HOC ANALYSIS OF PLACEBO RESPONDERS Howard A. Hassman, Sean Haley CRI Worldwide Mount Laurel, NJ, USA Background: It is well documented that placebo response rates for CNS studies conducted in the United States have gradually increased and that many clinical trials fail to achieve statistical significance. Numerous factors have been attributed to these failed clinical trials including misplaced site enrollment incentives, inflated entry scores, and the use of inappropriate or “professional” patients. Hence, it has been argued that some enrolled patients have not been truly valid treatment candidates for the study. Methods: We began a post-hoc analysis of unblinded data from 12 adult clinical trials conducted for different pharmaceutical sponsors between 2002 and 2009. All studies were conducted by CRIWW (Mount Laurel, New Jersey). Therapeutic areas included Generalized Anxiety Disorder (GAD), Major Depressive Disorder (MDD), Bipolar Depression, and Schizophrenia. We examined the available data from all patients relative to demographic variables, baseline efficacy measures, psychopharmacologic treatment history, psychiatric history and co-morbid medical diagnoses, as well as their previous participation in clinical trials. Analysis of the data included general descriptive statistics and T-tests for equality of variance. Results: Data relative to the following questions will be presented: 1) Do any demographic variables predict placebo response? 2) Does a previous history of psychopharmacologic treatment affect placebo response? 3) Do co-morbid medical or psychiatric diagnoses affect placebo response? 4) Does previous participation in clinical trials affect placebo response? Discussion: In this preliminary analysis of a small sample of unblinded clinical trials, there was no relationship between treatment outcome in the current trial with patient demographic variables, co-morbid medical or psychiatric diagnoses, or previous participation in a clinical trial. Of note, it was difficult to obtain unblinded data from sponsors and fewer than 15% of studies conducted by CRIWW between 2002 and 2009 had available data for review. Prior to 2006, it was uncommon to collect systematic data about previous participation in clinical trials or detailed treatment response histories. CRIWW has begun a program to collect this data on all patients in all studies going forward. The analysis of unblinded treatment outcomes from CNS trials relative to patient demographic characteristics and past clinical trials experience can improve our understanding of patient selection variables and enhance the precision of patient selection for future trials. doi:10.1016/j.schres.2010.02.230
Poster 3 IMPROVEMENT OF PHENOTYPING IN GENOME WIDE ASSOCIATION STUDIES ON SCHIZOPHRENIA: AN APPLICATION OF LATENT CLASS FACTOR ANALYSIS Eske M. Derks1, Judith Allardyce2, Marco P. Boks1, Roel A. Ophoff3 GROUP XX1 1 Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, Utrecht, Netherlands; 2 Department of Psychiatry and Neuropsychology, South Limburg Mental Health Research and Teaching Network, EURON, Maastricht University Medical Centre Maastricht Netherlands; 3Complex Genetics Section, Department of Biomedical Genetics, University Medical Center Utrecht Utrecht, Utrecht, Netherlands Background: Genetic factors explain a large proportion (81%) of the variation in schizophrenia. Nevertheless, the identification of specific
Abstracts
ziprasidone, n = 8 for olanzapine). The sensitivity analysis incorporating unattended or ill-defined causes of death (R98 and R99) yielded a similar result (RR = 0.73, 95% CI: 0.44, 1.22). Further, the supplemental sensitivity analysis resulted in a risk ratio of 0.99 (95% CI: 0.65, 1.50). Discussion: ZODIAC is the largest randomized study of patients with schizophrenia conducted to date. With substantial statistical power, the study did not detect an increased risk of non-suicide death associated with the use of ziprasidone vs. olanzapine. Post hoc readjudication analyses of mortality events supported the initial findings that there is no increased risk of sudden death comparing persons randomized to ziprasidone vs. olanzapine across all endpoints. doi:10.1016/j.schres.2010.02.227
POSTER SESSION 1 & LUNCH Sunday, 11 April, 2010 -12:00 pm -1:30 pm Poster 1 FACTORIAL ANALYSIS OF PSYCHOTIC LIKE EXPERIENCES AND HELP SEEKING BEHAVIOUR IN A COMMUNITY SAMPLE OF YOUNG ADULTS Marco Armando1,2,4,5, Saba Riccardo1, Righetti Valentino1, Dario Claudia1, Monducci Elena1,4, Girardi Paolo4, Nelson Barnaby3, Yung Alison3, Birchwood Maximilian2, Fiori Nastro Paolo1 1 PhD School “Early Intervention in Psychosis” “Sapienza” University Department of Psychiatry Rome, Italy, Italy; 2School of Psychology University of Birmingham Birmingham, UK, United Kingdom; 3Orygen Youth Health Research Centre, Centre for Youth Mental Health, University of Melbourne Victoria, Australia, Australia; 4PhD School “Early Intervention in Psychosis”, Sant' Andrea Hospital and “Sapienza” University of Rome NESMOS Department Rome, Italy, Italy; 5Department of Mental Health, Azienda Unità Sanitaria Locale di Viterbo Viterbo, Italy, Italy Background: Studies conducted in community samples suggest that psychotic-like experiences (PLEs) are common in the general population, leading to suggestions that they are either variations of normal personality or different expressions of vulnerability to psychotic disorder. This study aimed to determine if different subtypes of PLEs could be identified in a community sample of young adults and to investigate if particular subtypes were more likely to be associated with 4 poor mental health markers: psychosocial distress, depression, poor functioning and help-seeking. Methods: 997 students from two different italian universities participated in a cross-sectional multisite survey that measured PLEs using the Positive Scale of the Community Assessment of Psychic Experiences (CAPE), depression and distress using the Depression Scale and the Distress Scale of the CAPE, and functioning using the General Health Questionnaire-12 (GHQ-12). Factor analysis was conducted to identify any subtypes of PLEs. Results: Four subtypes of PLES were identified: Bizarre Experiences (BE), Perceptual Abnormalities (PA), Persecutory Ideas (PI), and Magical Thinking (MT). Intermittent, infrequent psychotic experiences were common, but frequent experiences were not. Only PI were strongly associated with all of the poor mental health markers. Discussion: Different subtypes of PLEs can be identified in this large sample, confirming the findings of our previous studies. This subtypes seem to be maladaptive in different ways and may therefore index different levels of risk of developing psychiatric disorders, compared to PLEs defined as an homogenous entity. doi:10.1016/j.schres.2010.02.229
Poster 2 EXAMINING PATIENT VALIDITY FOR CLINICAL: A POST-HOC ANALYSIS OF PLACEBO RESPONDERS Howard A. Hassman, Sean Haley CRI Worldwide Mount Laurel, NJ, USA Background: It is well documented that placebo response rates for CNS studies conducted in the United States have gradually increased and that many clinical trials fail to achieve statistical significance. Numerous factors have been attributed to these failed clinical trials including misplaced site enrollment incentives, inflated entry scores, and the use of inappropriate or “professional” patients. Hence, it has been argued that some enrolled patients have not been truly valid treatment candidates for the study. Methods: We began a post-hoc analysis of unblinded data from 12 adult clinical trials conducted for different pharmaceutical sponsors between 2002 and 2009. All studies were conducted by CRIWW (Mount Laurel, New Jersey). Therapeutic areas included Generalized Anxiety Disorder (GAD), Major Depressive Disorder (MDD), Bipolar Depression, and Schizophrenia. We examined the available data from all patients relative to demographic variables, baseline efficacy measures, psychopharmacologic treatment history, psychiatric history and co-morbid medical diagnoses, as well as their previous participation in clinical trials. Analysis of the data included general descriptive statistics and T-tests for equality of variance. Results: Data relative to the following questions will be presented: 1) Do any demographic variables predict placebo response? 2) Does a previous history of psychopharmacologic treatment affect placebo response? 3) Do co-morbid medical or psychiatric diagnoses affect placebo response? 4) Does previous participation in clinical trials affect placebo response? Discussion: In this preliminary analysis of a small sample of unblinded clinical trials, there was no relationship between treatment outcome in the current trial with patient demographic variables, co-morbid medical or psychiatric diagnoses, or previous participation in a clinical trial. Of note, it was difficult to obtain unblinded data from sponsors and fewer than 15% of studies conducted by CRIWW between 2002 and 2009 had available data for review. Prior to 2006, it was uncommon to collect systematic data about previous participation in clinical trials or detailed treatment response histories. CRIWW has begun a program to collect this data on all patients in all studies going forward. The analysis of unblinded treatment outcomes from CNS trials relative to patient demographic characteristics and past clinical trials experience can improve our understanding of patient selection variables and enhance the precision of patient selection for future trials. doi:10.1016/j.schres.2010.02.230
Poster 3 IMPROVEMENT OF PHENOTYPING IN GENOME WIDE ASSOCIATION STUDIES ON SCHIZOPHRENIA: AN APPLICATION OF LATENT CLASS FACTOR ANALYSIS Eske M. Derks1, Judith Allardyce2, Marco P. Boks1, Roel A. Ophoff3 GROUP XX1 1 Rudolf Magnus Institute of Neuroscience, University Medical Centre Utrecht, Utrecht, Netherlands; 2 Department of Psychiatry and Neuropsychology, South Limburg Mental Health Research and Teaching Network, EURON, Maastricht University Medical Centre Maastricht Netherlands; 3Complex Genetics Section, Department of Biomedical Genetics, University Medical Center Utrecht Utrecht, Utrecht, Netherlands Background: Genetic factors explain a large proportion (81%) of the variation in schizophrenia. Nevertheless, the identification of specific