- Email: [email protected]
0428 EFFECTIVENESS OF ANTIPSYCHOTIC TREATMENT IN NEVER TREATED PATIENTS WITH SCHIZOPHRENIA: 36-MONTH RESULTS FROM THE SCHIZOPHRENIA OUTPATIENTS HEALTH OUTCOMES (SOHO) STUDY
Posters, Theme 11: Biological interventions in FEP 0395 REMISSION IN SCHIZOPHRENIA: RESULTS FROM A 12-MONTH ANALYSIS OF LONG-ACTING RISPERIDONE IN PATIENTS WITH FIRST-EPISODE PSYCHOSIS R. Emsley1 *, P. Oosthuizen1 , L. Koen1 , D. Niehaus1 , A. Lex2 , R. Medori2 . 1 University of Stellenbosch, Cape Town, South Africa, 2 Janssen-Cilag GmbH, Neuss, Germany Presenting author contact: [email protected] Objectives: To assess the number of first-episode psychosis patients who attained remission status in a pre-specified, 12-month interim analysis from an ongoing 2-year open-label trial with long-acting risperidone (LAR). Methods: Eighteen women and 33 men with recent onset psychosis were enrolled. After 1 week of risperidone oro-dispersible tablets (1−3 mg), patients received 25 mg LAR every 2 weeks for 6 weeks, with flexible dosing thereafter (LAR 25−50 mg). Remission status was defined by Andreasen et al. [1]. Results: Fifty patients (mean baseline age 25.3±7.3 years) received LAR. Overall, 25 patients (50%) achieved remission by 12 months. Median time to remission was 213 days. Fourteen (78%) women and 11 (34%) men achieved remission. Remitted patients had greater improvements in PANSS total scores compared with non-remitted patients at week 4 (−25.7 vs −15.8, p = 0.0122) and week 6 (−30.2 vs −20.0, p = 0.0374). Patient function improved significantly over 12 months (p = 0.0001) and compared with non-remitted patients, remitted patients showed trends towards higher scores on the Social and Functioning Assessment Scale (p = 0.1660), Short Form-12 Mental Component Summary (52.3 vs 45.8, p = 0.0159) and Physical Component Summary (49.7 vs 44.0, p = 0.0766) scales at 12 months. Of patients who were not in full time employment at baseline, 52% remitted patients demonstrated an improvement in occupational status over 12 months compared with 31% non-remitted patients. Lower levels of resource use were seen in remitted patients compared with non-remitted patients with lower levels of re-hospitalization (1 vs 3 subjects) and emergency room visits (2 vs 4 subjects). Conclusion: In this interim analysis of first-episode psychosis, 50% of patients treated with LAR (25−50 mg) achieved remission at 12 months, with a trend towards greater improvements in function, health status, productivity and lower resource use. Reference(s) [1] 1. Andreasen NC et al. Am J Psychiatry 2005;162: 441–449.
0416 THE IMPACT OF MODAFINIL AS AN ADJUNCT TO A SECOND GENERATION ANTIPSYCHOTIC ON COGNITIVE FUNCTIONING IN PATIENTS WITH FIRST PSYCHOTIC EPISODE J. Leblanc *, K. L´etourneau, M.F. Demers, R.H. Bouchard, M.A. Roy. Centre hospitalier Robert Giffard, CRULRG, Qu´ebec, PQ, Canada Presenting author contact: [email protected] Cognitive deficits are frequently encountered in psychotic patients. Those deficits handicap patient’s general functioning and autonomy. Very few options are available to manage such problems. In order to verify the impact of adding a new enhancer of vigilance, modafinil, to second generation antipsychotic, we are conducting a study in thirty stable adults (no score 5 at PANSS positive symptoms subscale) with schizophrenia or related psychosis, experiencing attention deficits (scores Z = −1.00 at Color Trail Test, Mesulam
S131 and Weintraub Cancellation Test, Stroop Test or Continuous Performance Test-II). Patients with recent panic attacks or panic disorder are excluded. In a ten weeks, randomized, prospective, double-blind, cross-over study, patients are exposed to 100 mg daily of placebo or modafinil for two weeks then, to 200 mg daily for the two following weeks. A two weeks wash-out period is taking place before the same sequence is started again. Patient is thus exposed one month to placebo and one month to modafinil, or conversely, in a random fashion. Dose can be reduced, according to tolerance. Assessments, performed at baseline and at the end of each treatment sequence, include neurocognitive standardized battery, psychological tools (PANS, CGI, SOFAS, SDS), side effects (UKU, ESRS, DAI), vital signs, anthropometric and metabolic profile. In a previous pilot study conducted by our group, modafinil has been successfully added in five young psychotic patients with cognitive deficits. A significant and rapid improvement was reported, particularly on attention and verbal fluency, without any psychotic exacerbation. However, anxious patients required lower titration and dose. This new pharmacological avenue may raised innovative perspective in the management of cognitive deficits and may represent a major advance to support recovery of schizophrenic patients. 0428 EFFECTIVENESS OF ANTIPSYCHOTIC TREATMENT IN NEVER TREATED PATIENTS WITH SCHIZOPHRENIA: 36-MONTH RESULTS FROM THE SCHIZOPHRENIA OUTPATIENTS HEALTH OUTCOMES (SOHO) STUDY D. Novick1 *, D. Suarez2 , I. Gasquet3 , J.M. Haro2 . 1 Eli Lilly and Company, Windlesham, United Kingdom, 2 Research & Development Unit, Sant Joan de D´eu-SSM, Sant Boi, Barcelona, Spain, 3 Public Health Department – Paul Brousse Hospital (AP-HP), Villejuif, France Presenting author contact: [email protected] Objectives: To compare relative effectiveness, in terms of treatment discontinuation, of olanzapine, risperidone, and typical (oral and depot) antipsychotic medications in previously never treated outpatients with schizophrenia during 3 years follow-up. Methods: SOHO is a 3-year, prospective, observational study of health outcomes associated with antipsychotic treatment. 10,972 patients were enrolled in SOHO. The subgroup of previously untreated patients with schizophrenia was obtained from the population of individuals participating in SOHO. Never-treated patients were defined as patients who (i) had never received antipsychotic treatment for schizophrenia and (ii) had not received antipsychotic treatment in the 6 months prior to study inclusion. Treatment discontinuation was defined as discontinuing, adding to or switching the medication prescribed at baseline. A Cox proportional-hazards regression model was used in order to adjust for baseline differences between treatments groups. Results: 1009 patients started antipsychotic monotherapy out of the 1038 never treated patients enrolled at baseline; 936 (90.2%) have at least a follow-up visit and were included in the analysis. Approximately 59% of the patients were male and mean age was 34.01 (sd 13.23) years. Approximately 31.90% of the patients discontinued the medication initiated at baseline during the three years. Frequencies for each medication were: typical antipsychotics (44.51%), risperidone (36.16%) and olanzapine (28.91%). A Cox regression showed that patients taking typical antipsychotic medica-
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tions (Hazard ratio 1.75; 95% CI: 1.11−2.78), and risperidone (1.36; 1.02−1.82), had an increased risk of discontinuing their baseline medication compared to patients taking olanzapine. A higher positive CGI score at baseline was also associated to higher risk of discontinuing treatment (1.18; 1.06−1.30). Conclusions: Treatment effectiveness varied among medications. Olanzapine was the most effective in terms of the rates of discontinuation. Clinical severity but neither gender nor age were associated with risk of discontinuing treatment. Results should be interpreted conservatively due to the observational study design. 0434 PHARMACOLOGICAL TREATMENTS AMONG SUBJECTS REFERRED TO A PSYCHIATRIC OUTPATIENT CLINIC FOR EMERGING PSYCHOLOGICAL DISORDERS (PREPP RESEARCH PROGRAM) O. Canceil *, J.P. Fidani, A. Sacco, M.O. Krebs. SHU & INSERM U796, Hˆopital Sainte Anne, Paris, France Presenting author contact: [email protected] The purpose of our study was to evaluate pharmacological treatments received by subjects consulting for the first time in a psychiatric outpatient clinic for emerging psychological disorders in adolescents and young adults. From January 2004 to December 2005, 206 subjects have been assessed through a standard psychiatric evaluation protocol. ICD-10 criteria for schizophrenia were already fulfilled for 15% of patients. 14% of patients suffered from anxiety disorders and 10% from mood disorders. 42% needed to be followed for a more precise diagnosis and were referred to the PREPP research program, in which clinical evaluation is completed by the CAARMS (Clinical Assessment of At Risk Mental States; Young et al, 2005) and repeated every six months. The main purpose of the PREPP program is to identify factors that can predict transition to schizophrenia. 100 cases were randomly chosen among the 206 subjects population. 73% have never received any psychotropic treatment. 15% received antipsychotic, 10% antidepressant and 3% anxiolytic treatments, when they were referred to our outpatient clinic for emerging psychological disorders. Among 32 subjects with an “at risk mental state” according to the CAARMS, 36% received antidepressants alone, 16% antipsychotic treatment alone and 6% both of them. Whereas, among 24 subjects recognized as “psychotic” according to the CAARMS, 17% received antidepressants alone, 54% antipsychotic treatment alone and 17% both of them. Antidepressant treatment is a frequent strategy chosen in a first stage by general practitioners and private psychiatrists, to treat patients at risk for psychosis. 0436 UTILIZING CREATIVE STRATEGIES TO ASSESS FOR METABOLIC SYNDROMES IN FIRST EPISODE PSYCHOSIS L.D. Hassall *, S. Northcott, J. Swann-Merrison, C. Taylor, J. Lynch, R. Manchanda. London Health Sciences Centre, London, Ontario, Canada Presenting author contact: [email protected] Introduction: Evidence suggests the need for greater attention to metabolic side effects related to second generation antipsychotics. However, it can be challenging to engage clients in attending early morning fasting glucose and lipid profile testing. In an attempt
Abstracts to attract a large cohort of early psychosis patients for diabetes and cholesterol screening, therapeutic recreational activities were implemented. Methods: A “fun fair”, utilizing the principles of therapeutic recreation, was implemented at a first episode program to screen for metabolic abnormalities. Forty-three patients attended the event and were screened for lipid profiles, fasting glucose, 2 hour pc glucose (post 75 gram challenge) and prolactin levels. Height, weight and abdominal circumference were measured by one clinician to ensure consistency. Results: One patient was unable to participate in the oral glucose tolerance test as she had an elevated fasting glucometer reading. None of the patients had a fasting venous glucose >7 mmol/L. Two patients had impaired fasting venous glucose readings (6.1−6.9 mmol/L), three patients had impaired glucose tolerance (7.8−11.1 mmol/L) 2 hours post 75 gm glucose load and one patient had a plasma glucose >11.1 mmol/L meeting the criteria for diabetes. Using the 2003 Canadian guidelines for the management of dyslipidemia – nine patients met criteria for high risk of coronary artery disease or non-fatal myocardial infarction in 10 years, while 18 patients were considered to be at moderate risk. Discussion: Offering a therapeutic recreational event within a metabolic screening clinic can be a valuable tool in attracting early psychosis patients’ participation, facilitating the accumulation of valuable health information. 0437 ANALYSIS OF CLIENT’S REPORTS OF THE RELATIONSHIP THAT EXISTS BETWEEN PHYSICAL AND MENTAL HEALTH IN FIRST EPISODE PSYCHOSIS C. Neels *, M. Crocker, R. Norman, R. Harricharan. London Health Science Centre, London, Ontario, Canada Presenting author contact: [email protected] Aims: 1. To assess the attitudes of those with first episode psychosis towards physical health and fitness. 2. To identify barriers to improve physical health and fitness. 3. To implement and evaluate a program designed to improve fitness and health. Methods: A first episode program initiated a Healthy Living Group. As part of this initiative, information was collected on their present fitness and health needs prior to the group as well as barriers to meeting these needs. The intervention of a Healthy Living Group at the community YMCA was introduced. Participants were enrolled in the group for an 8-week rotation. Each participant also completed a Post group health questionnaire, which identified benefits, goal attainment and barriers to achieving personal goals as set out at the beginning of the 8weeks. Results: 83% of respondents were found to be smokers and identified gaining muscle tone and shape and improving energy as their primary fitness goal. 50% reported that lack of time; decreased motivation and energy were the most consistent barriers to maintaining weekly attendance. While motivational issues interfered with a small proportion of participants in continuing with the program over 50% completed the group. At the end of 8 weeks verbal reports from both client and family suggest improved quality of life in the areas of increased energy, self-esteem, confidence and socialization. Discussion: Incorporating physical health and wellness into the treatment plan for first episode patients can result in a variety of positive gains including the reduction of stigma. Participants reported improvements in the areas of improved sleep, energy and motivation, socialization. Attitudes towards health and fitness of the
0416 THE IMPACT OF MODAFINIL AS AN ADJUNCT TO A SECOND GENERATION ANTIPSYCHOTIC ON COGNITIVE FUNCTIONING IN PATIENTS WITH FIRST PSYCHOTIC EPISODE J. Leblanc *, K. L´etourneau, M.F. Demers, R.H. Bouchard, M.A. Roy. Centre hospitalier Robert Giffard, CRULRG, Qu´ebec, PQ, Canada Presenting author contact: [email protected] Cognitive deficits are frequently encountered in psychotic patients. Those deficits handicap patient’s general functioning and autonomy. Very few options are available to manage such problems. In order to verify the impact of adding a new enhancer of vigilance, modafinil, to second generation antipsychotic, we are conducting a study in thirty stable adults (no score 5 at PANSS positive symptoms subscale) with schizophrenia or related psychosis, experiencing attention deficits (scores Z = −1.00 at Color Trail Test, Mesulam
S131 and Weintraub Cancellation Test, Stroop Test or Continuous Performance Test-II). Patients with recent panic attacks or panic disorder are excluded. In a ten weeks, randomized, prospective, double-blind, cross-over study, patients are exposed to 100 mg daily of placebo or modafinil for two weeks then, to 200 mg daily for the two following weeks. A two weeks wash-out period is taking place before the same sequence is started again. Patient is thus exposed one month to placebo and one month to modafinil, or conversely, in a random fashion. Dose can be reduced, according to tolerance. Assessments, performed at baseline and at the end of each treatment sequence, include neurocognitive standardized battery, psychological tools (PANS, CGI, SOFAS, SDS), side effects (UKU, ESRS, DAI), vital signs, anthropometric and metabolic profile. In a previous pilot study conducted by our group, modafinil has been successfully added in five young psychotic patients with cognitive deficits. A significant and rapid improvement was reported, particularly on attention and verbal fluency, without any psychotic exacerbation. However, anxious patients required lower titration and dose. This new pharmacological avenue may raised innovative perspective in the management of cognitive deficits and may represent a major advance to support recovery of schizophrenic patients. 0428 EFFECTIVENESS OF ANTIPSYCHOTIC TREATMENT IN NEVER TREATED PATIENTS WITH SCHIZOPHRENIA: 36-MONTH RESULTS FROM THE SCHIZOPHRENIA OUTPATIENTS HEALTH OUTCOMES (SOHO) STUDY D. Novick1 *, D. Suarez2 , I. Gasquet3 , J.M. Haro2 . 1 Eli Lilly and Company, Windlesham, United Kingdom, 2 Research & Development Unit, Sant Joan de D´eu-SSM, Sant Boi, Barcelona, Spain, 3 Public Health Department – Paul Brousse Hospital (AP-HP), Villejuif, France Presenting author contact: [email protected] Objectives: To compare relative effectiveness, in terms of treatment discontinuation, of olanzapine, risperidone, and typical (oral and depot) antipsychotic medications in previously never treated outpatients with schizophrenia during 3 years follow-up. Methods: SOHO is a 3-year, prospective, observational study of health outcomes associated with antipsychotic treatment. 10,972 patients were enrolled in SOHO. The subgroup of previously untreated patients with schizophrenia was obtained from the population of individuals participating in SOHO. Never-treated patients were defined as patients who (i) had never received antipsychotic treatment for schizophrenia and (ii) had not received antipsychotic treatment in the 6 months prior to study inclusion. Treatment discontinuation was defined as discontinuing, adding to or switching the medication prescribed at baseline. A Cox proportional-hazards regression model was used in order to adjust for baseline differences between treatments groups. Results: 1009 patients started antipsychotic monotherapy out of the 1038 never treated patients enrolled at baseline; 936 (90.2%) have at least a follow-up visit and were included in the analysis. Approximately 59% of the patients were male and mean age was 34.01 (sd 13.23) years. Approximately 31.90% of the patients discontinued the medication initiated at baseline during the three years. Frequencies for each medication were: typical antipsychotics (44.51%), risperidone (36.16%) and olanzapine (28.91%). A Cox regression showed that patients taking typical antipsychotic medica-
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tions (Hazard ratio 1.75; 95% CI: 1.11−2.78), and risperidone (1.36; 1.02−1.82), had an increased risk of discontinuing their baseline medication compared to patients taking olanzapine. A higher positive CGI score at baseline was also associated to higher risk of discontinuing treatment (1.18; 1.06−1.30). Conclusions: Treatment effectiveness varied among medications. Olanzapine was the most effective in terms of the rates of discontinuation. Clinical severity but neither gender nor age were associated with risk of discontinuing treatment. Results should be interpreted conservatively due to the observational study design. 0434 PHARMACOLOGICAL TREATMENTS AMONG SUBJECTS REFERRED TO A PSYCHIATRIC OUTPATIENT CLINIC FOR EMERGING PSYCHOLOGICAL DISORDERS (PREPP RESEARCH PROGRAM) O. Canceil *, J.P. Fidani, A. Sacco, M.O. Krebs. SHU & INSERM U796, Hˆopital Sainte Anne, Paris, France Presenting author contact: [email protected] The purpose of our study was to evaluate pharmacological treatments received by subjects consulting for the first time in a psychiatric outpatient clinic for emerging psychological disorders in adolescents and young adults. From January 2004 to December 2005, 206 subjects have been assessed through a standard psychiatric evaluation protocol. ICD-10 criteria for schizophrenia were already fulfilled for 15% of patients. 14% of patients suffered from anxiety disorders and 10% from mood disorders. 42% needed to be followed for a more precise diagnosis and were referred to the PREPP research program, in which clinical evaluation is completed by the CAARMS (Clinical Assessment of At Risk Mental States; Young et al, 2005) and repeated every six months. The main purpose of the PREPP program is to identify factors that can predict transition to schizophrenia. 100 cases were randomly chosen among the 206 subjects population. 73% have never received any psychotropic treatment. 15% received antipsychotic, 10% antidepressant and 3% anxiolytic treatments, when they were referred to our outpatient clinic for emerging psychological disorders. Among 32 subjects with an “at risk mental state” according to the CAARMS, 36% received antidepressants alone, 16% antipsychotic treatment alone and 6% both of them. Whereas, among 24 subjects recognized as “psychotic” according to the CAARMS, 17% received antidepressants alone, 54% antipsychotic treatment alone and 17% both of them. Antidepressant treatment is a frequent strategy chosen in a first stage by general practitioners and private psychiatrists, to treat patients at risk for psychosis. 0436 UTILIZING CREATIVE STRATEGIES TO ASSESS FOR METABOLIC SYNDROMES IN FIRST EPISODE PSYCHOSIS L.D. Hassall *, S. Northcott, J. Swann-Merrison, C. Taylor, J. Lynch, R. Manchanda. London Health Sciences Centre, London, Ontario, Canada Presenting author contact: [email protected] Introduction: Evidence suggests the need for greater attention to metabolic side effects related to second generation antipsychotics. However, it can be challenging to engage clients in attending early morning fasting glucose and lipid profile testing. In an attempt
Abstracts to attract a large cohort of early psychosis patients for diabetes and cholesterol screening, therapeutic recreational activities were implemented. Methods: A “fun fair”, utilizing the principles of therapeutic recreation, was implemented at a first episode program to screen for metabolic abnormalities. Forty-three patients attended the event and were screened for lipid profiles, fasting glucose, 2 hour pc glucose (post 75 gram challenge) and prolactin levels. Height, weight and abdominal circumference were measured by one clinician to ensure consistency. Results: One patient was unable to participate in the oral glucose tolerance test as she had an elevated fasting glucometer reading. None of the patients had a fasting venous glucose >7 mmol/L. Two patients had impaired fasting venous glucose readings (6.1−6.9 mmol/L), three patients had impaired glucose tolerance (7.8−11.1 mmol/L) 2 hours post 75 gm glucose load and one patient had a plasma glucose >11.1 mmol/L meeting the criteria for diabetes. Using the 2003 Canadian guidelines for the management of dyslipidemia – nine patients met criteria for high risk of coronary artery disease or non-fatal myocardial infarction in 10 years, while 18 patients were considered to be at moderate risk. Discussion: Offering a therapeutic recreational event within a metabolic screening clinic can be a valuable tool in attracting early psychosis patients’ participation, facilitating the accumulation of valuable health information. 0437 ANALYSIS OF CLIENT’S REPORTS OF THE RELATIONSHIP THAT EXISTS BETWEEN PHYSICAL AND MENTAL HEALTH IN FIRST EPISODE PSYCHOSIS C. Neels *, M. Crocker, R. Norman, R. Harricharan. London Health Science Centre, London, Ontario, Canada Presenting author contact: [email protected] Aims: 1. To assess the attitudes of those with first episode psychosis towards physical health and fitness. 2. To identify barriers to improve physical health and fitness. 3. To implement and evaluate a program designed to improve fitness and health. Methods: A first episode program initiated a Healthy Living Group. As part of this initiative, information was collected on their present fitness and health needs prior to the group as well as barriers to meeting these needs. The intervention of a Healthy Living Group at the community YMCA was introduced. Participants were enrolled in the group for an 8-week rotation. Each participant also completed a Post group health questionnaire, which identified benefits, goal attainment and barriers to achieving personal goals as set out at the beginning of the 8weeks. Results: 83% of respondents were found to be smokers and identified gaining muscle tone and shape and improving energy as their primary fitness goal. 50% reported that lack of time; decreased motivation and energy were the most consistent barriers to maintaining weekly attendance. While motivational issues interfered with a small proportion of participants in continuing with the program over 50% completed the group. At the end of 8 weeks verbal reports from both client and family suggest improved quality of life in the areas of increased energy, self-esteem, confidence and socialization. Discussion: Incorporating physical health and wellness into the treatment plan for first episode patients can result in a variety of positive gains including the reduction of stigma. Participants reported improvements in the areas of improved sleep, energy and motivation, socialization. Attitudes towards health and fitness of the