- Email: [email protected]
P.3.c.049 Risk of adverse health outcome and metabolic syndrome in adolescents treated with antipsychotics: preliminary results
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P.3.c. Psychotic disorders and antipsychotics − Antipsychotics (clinical)
and Olanzapine were associated with the highest prevalences of obesity, dysglycaemia and hypertiglyceridaemia. Amisulpride, Aripiprazole and Ziprasidone were associated with lower prevalences of dysglycaemia but patients treated with Amisulpride presented frequent hypercholesterolaemia. Obesity rate was higher in women than in men and age influence was detected in diabetes. Schizophrenic group presented higher rate of comorbidity than the other groups analyzed with statistical significance. Conclusions: Psychotic patients present frequent comorbidity with psychiatric and non-psychiatric illness. The results observed in this study emphasise the need for careful evaluation of patients with psychotic disorders treated with antipsychotic drugs to detect the occurrence of metabolic disorders and other psychiatric comorbidities.
P.3.c.048 Demographic and clinical characteristics of 80 female patients treated with long-acting risperidone during 4 years V. Dominis1 ° , A. Loncar Vuina1 , A. Silic1 , M. Mihanovic1 . 1 Psychiatric Hospital “Sveti Ivan”, Department of acute psychiatry, Zagreb, Croatia Purpose of the study: Antipsychotic medication is essential component of therapy of psychotic disorders. Development of atypical antipsychotics offered an important advance in control of psychotic disorders. Long-acting injectable formulations of antipsychotics have prolonged duration of action, trough that they provide better control of psychotic symptoms [1]. Risperidone long-acting injection (RLAI) has been shown to improve clinical parameters, to decrease relapse rate and increase adherence in patients suffering from psychotic disorders [2]. Risperidone longacting injection is momentarily only long-acting second generation antipsychotic reimbursed in Croatia and it is registered for treatment of positive and negative symptoms of schizophrenia. However, literature data suggest that in clinical practice risperidone long-acting injection is also being used in treatment of different “off-label” conditions, such as schizoaffective disorder, bipolar affective disorder, psychotic episodes in personality disorders and behavioural disturbances associated with dementia [3]. Objective of this poster is to describe demographic and clinical features of acute psychiatric ward female patients, who were in everyday practice clinically estimated as suitable for risperidone long-acting injection treatment. Methods: Research included all patients treated with risperidone long-acting injection, in inpatient and outpatient setting of acute female ward of Psychiatric Hospital “Sveti Ivan” in Zagreb, Croatia, over time period of 4 years − from January 2007 to December 2010. Three different psychiatrists, who are permanently working on acute psychiatric ward since January 2007, have diagnosed and treated patients. Patients have been diagnosed by criteria of International Classification of Diseases (ICD), 10th revision. Data were collected by computerized search of digitalized medical records of Psychiatric Hospital “Sveti Ivan”. Summary of results: Research sample included 80 female patients. Presented demographic data include patients’ age, marital status, number of children, level of education, employment status, residency in rural or urban area and information about patients’ household arrangements. Presented clinical characteristics include diagnosis of psychiatric disorder, portion of patients experiencing first episode of disorder, information about presence of suicidal thoughts and attempts, formulation of previously prescribed
antipsychotic therapy, inpatient or outpatient status of patients at time when risperidone long-acting injection therapy was prescribed, prescribed doses of risperidone long-acting injection and information about presence of concomitant psychopharmacological therapy at time when risperidone long-acting injection was prescribed. Final results will be summarized at the end of July, when the research will be completed. Conclusions: Poster data represent overview of our clinical experience with risperidone long-acting injection in naturalistic setting of an acute female ward in psychiatric hospital, over period of 4 years. Presented data describe demographic and clinical features of patients who were considered to be suitable for risperidone long-acting injection treatment and who were expected to gain benefit from it. Results show that in every day clinical work risperidone long-acting injection is being used for treatment of several “off-label” conditions. References [1] Apiquian, R., C´ordoba, R., Louz˜a M., 2011 Clinical outcomes of longacting injectable risperidone in patients with schizophrenia: six-month follow-up from the Electronic Schizophrenia Treatment Adherence Registry in Latin America. Neuropsychiatric Disease and Treatment 7, 19−26. [2] Su, K.P., Chang, H.C., Tsai, S.J., Yen, F.C., Tang, C.H., 2009 Relapse and long-acting injectable risperidone: a 1-year mirror image study with a national claims database in Taiwan. Value Health 12:3, 118−21. [3] Stahl, S.M., 2008 Stahl’s Essential Psychopharmacology: neuroscientific basis and practical applications − 3rd ed. Cambridge University Press, 412−13.
P.3.c.049 Risk of adverse health outcome and metabolic syndrome in adolescents treated with antipsychotics: preliminary results J. Merch´an-Naranjo1 ° , M. Gir´aldez-Quiroga2 , C. Moreno1 , L. Pina1 , M. Parellada1 , C. Tapia1 , P. Rodr´ıguez1 , C. Arango1 . 1 Hospital General Universitario Gregorio Mara˜ no´ n, Child and Adolescent Psychiatry Department. Centro de Investigaci´on Biom´edica en Red de Salud Mental CIBERSAM, Madrid, Spain; 2 Hospital General Universitario Gregorio Mara˜ no´ n, Pharmacy Deparment, Madrid, Spain Background: In recent years, several studies have demonstrated that second-generation antipsychotics (SGAs) induce metabolic adverse effects (defined as metabolic syndrome), such as weight gain, dyslipidemia, and hyperglycemia, including new-onset type 2 diabetes mellitus, which contribute to cardiovascular disease among others. The aim of this study was to analyse the development of metabolic syndrome, defined as the presence of three of the following abnormalities: obesity with BMI 95th percentile, blood pressure > 90th percentile, triglyceride level > 110 mg/dL, HDL cholesterol level <40 mg/dL, and glucose level 110 mg/dL [1] and patients “at risk for adverse health outcome,” defined as BMI 95th percentile or BMI 85th percentile plus presence of one other obesity-related complication, i.e. hypertension, dyslipidaemia, or hyperglycaemia [2], [3]. These adverse effects, along with lifestyle and genetic predisposition, may contribute to shorter life expectancy in patients receiving SGA treatment compared with the general population. Methods: The patients enrolled in this study were drawn from a naturalistic longitudinal multicentre study conducted at four child and adolescent psychiatry units in Spain. The study sample was composed of 235 children and adolescents with any psychiatry diagnosis (mean age: 14.33±3.04 years, 141 males,
P.3.c. Psychotic disorders and antipsychotics − Antipsychotics (clinical) 88.51% Caucasian). Of those, 116 patients were antipsychoticna¨ıve (no prior treatment with antipsychotic) and 119 patients were quasi antipsychotic-na¨ıve (less than 30 days prior antipsychotic exposure) at the time of the baseline assessment. Treatments at baseline were as follows: risperidone (N = 75), olanzapine (N = 22), quetiapine (N = 17), haloperidol (N = 3), pimozide and chlorpromazine 1 patient, respectively. Patients were divided into three diagnostic groups: schizophrenia or any other disorder with psychotic symptoms (N = 93), bipolar disorder (N = 38), and other diagnosis (N = 104). At baseline and the 3, 6, and 12 month visits after baseline, we collected laboratory test results (glycosylated haemoglobin (HbA1c), insulin, insulin resistance, glucose, triglycerides, and cholesterol levels) and physical examination data (weight, height, Body Mass Index (BMI) (weight in kilograms/ height in meters squared [kg/m2 ]), and blood pressure (BP)). BMI was adjusted for age and gender by conversion to a z-score with Spanish normative charts. A descriptive analysis was performed using SPSS 16.0 (Windows version). Results: The number of children and adolescents at risk of developing metabolic syndrome at 3, 6, and 12 months was 21.97% (N = 40), 24.47% (N = 35), and 33.3% (N = 34), respectively. In addition, the number of patients who presented metabolic syndrome during the same period of time was 3.3% (N = 6), 6.29% (N = 9), and 6.86% (N = 7), respectively. Conclusions: The risk for adverse health outcome and development of metabolic syndrome appears after 3 months of antipsychotic treatment and it does not reverse, but rather increases during long-term treatment. These adverse events should be monitored in children and adolescent treated with antipsychotics throughout the entire treatment period. References [1] Cook S, Weitzman M, Auinger P, Nguyen M, Dietz W. 2003. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third National Health and Nutrition Examination Survey 1988–1994. Arch Pediatr Adolesc Med.; 157: 821−7. [2] Moreno C, Merch´an-Naranjo J, Alvarez M, Baeza I, Alda JA, Mart´ınezCantarero C, Parellada M, S´anchez B, de la Serna E, Gir´aldez M, Arango C. 2010. Metabolic effects of second-generation antipsychotics in bipolar youth: comparison with other psychotic and nonpsychotic diagnoses. Bipolar Disord. Mar; 12(2): 172−84. [3] Fraguas D, Merch´an-Naranjo J, Laita P, Parellada M, Moreno D, RuizSancho A, Cifuentes A, Gir´aldez M, Arango C. 2008. Metabolic and hormonal side effects in children and adolescents treated with secondgeneration antipsychotics. J Clin Psychiatry. Jul; 69(7): 1166−75. Disclosure statement: Supported by the Spanish Ministry of Health and Social Policy, Spanish Ministry of Science and Innovation, Instituto de Salud Carlos III, Centro de Investigaci´on Biom´edica en Red de Salud Mental, CIBERSAM, (Madrid, Spain). Dr. Arango has served as a consultant for to or has received honoraria from AstraZeneca, Bristol-Myers Squibb, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Roche, Servier, and ScheringPlough. AstraZeneca, Bristol-Myers Squibb, Fundaci´on Alicia Koplowitz, Fundaci´on Marcelino Bot´ın, Janssen, Pfizer, Schering-Plough, Servier, Spanish Ministry of Health and Spanish Ministry of Science and Innovation. Dr. Moreno has served as a consultant for Astra Zeneca, Bristol-Myers Squibb, and Otsuka. Dr. M. Parellada has received travel support from Astra-Zeneca and Juste. The rest of the authors declare no conflicts of interest.
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P.3.c.050 Antipsychotic monotherapy versus polypharmacy in patients with serious mental illness P. Ntounas1 ° , C. Tsopelas2 , A. Konsta3 , E. Rizos4 , A. Diakoumopoulou5 , P. Gkikas6 , E. Siouti1 , C. Touloumis1 , 1 Psychiatric Hospital of A. Douzenis4 , L. Lykouras4 . Attica, 10 th Dept of Psychiatry, Athens, Greece; 2 Psychiatric Hospital of Attica, 5 th Dept of Psychiatry, Athens, Greece; 3 Aristotle University of Thessaloniki Papageorgiou General Hospital, 1st Dept of Psychiatry, Thessaloniki, Greece; 4 National and Kapodistrian University of Athens Attikon General Hospital, 2 nd Dept of Psychiatry, Athens, Greece; 5 Psychiatric Hospital of Attica, 4 th Dept of Psychiatry, Athens, Greece; 6 Psychiatric Hospital of Attica, 6 th Dept of Psychiatry, Athens, Greece Objective: Monotherapy is recognized as the preferred mode of treatment, because it permits documenting patient’s response to an adequate trial of each medication, helping to reduce the complexity of the medication regimen, reducing the risk of adverse events, and making it easier to assess and manage future symptom exacerbations. Despite lack of endorsement by clinical treatment guidelines, the practice of antipsychotic polypharmacy continues to increase. A review of the literature finds that the overall point prevalence of antipsychotic polypharmacy ranges anywhere from 4.1% to 69%. In the literature there are case reports and open uncontrolled, nonrandomized trials, reporting increased incidence of serious adverse events such as hyperprolactinemia, akathisia, hypersalivation and even an increased risk of mortality when performing polypharmacy. Nowadays is accepted clinical practice the concurrent use of two or more antipsychotics in the hope that lower dosages of each agent may reduce the occurrence of adverse effects and/or that the combination may maintain or even enhance efficacy. The primary objective of this study was to compare monotherapy with polypharmacy in patients with serious mental disorder admitted in a big psychiatric hospital, regarding efficacy, compliance and presence of side effects for a 6 months follow up period. Methodology: 86 participants were randomly selected from a population of 1186 in-patients with diagnosis of schizophrenia, bipolar disorder, depression and other (substance abuse/general medical condition). Psychopathological assessment, carried out by 5 experienced adult psychiatrists, using the Structured Clinical Interview for DSM-IV axis-I disorders (SCID-I/P). Patients were assessed at baseline and at 3-monthly and 6-monthly intervals. Demographic data were obtained from patients medical chart. The SPSS statistical package was used throughout. Results: The sample consisted of 86 participants, 64% men, 36% women, mean age: 44.27 (sd = 10.1). The great majority had many admissions and 70.9% had diagnosis of Schizophrenia, 12.8% Bipolar disorder, 10.5% Depression and 5.8% other (Substance abuse/organic disease). 57% were on monotherapy and 43% were on two or more antipsychotics. Males were preferably on polypharmacy when compared to women (x2 = 3.9, df = 1, p 0.005) although there were not at baseline any differences in the severity of mental disorder, metabolic parameters, side effects and compliance. This lack of differences in compliance and lack of side effects (AST, ALT, g-GT, Blood Pressure, QTc, EPS, GLU tolerance, body weight differences) were maintainted thoughout the 6 months follow up, and there was also a tendency to consider monotherapy not effective (not statistically significant results). Conclusions: This study suggests that individuals with schizophrenia who are receiving two or even more antipsychotics, and
P.3.c. Psychotic disorders and antipsychotics − Antipsychotics (clinical)
and Olanzapine were associated with the highest prevalences of obesity, dysglycaemia and hypertiglyceridaemia. Amisulpride, Aripiprazole and Ziprasidone were associated with lower prevalences of dysglycaemia but patients treated with Amisulpride presented frequent hypercholesterolaemia. Obesity rate was higher in women than in men and age influence was detected in diabetes. Schizophrenic group presented higher rate of comorbidity than the other groups analyzed with statistical significance. Conclusions: Psychotic patients present frequent comorbidity with psychiatric and non-psychiatric illness. The results observed in this study emphasise the need for careful evaluation of patients with psychotic disorders treated with antipsychotic drugs to detect the occurrence of metabolic disorders and other psychiatric comorbidities.
P.3.c.048 Demographic and clinical characteristics of 80 female patients treated with long-acting risperidone during 4 years V. Dominis1 ° , A. Loncar Vuina1 , A. Silic1 , M. Mihanovic1 . 1 Psychiatric Hospital “Sveti Ivan”, Department of acute psychiatry, Zagreb, Croatia Purpose of the study: Antipsychotic medication is essential component of therapy of psychotic disorders. Development of atypical antipsychotics offered an important advance in control of psychotic disorders. Long-acting injectable formulations of antipsychotics have prolonged duration of action, trough that they provide better control of psychotic symptoms [1]. Risperidone long-acting injection (RLAI) has been shown to improve clinical parameters, to decrease relapse rate and increase adherence in patients suffering from psychotic disorders [2]. Risperidone longacting injection is momentarily only long-acting second generation antipsychotic reimbursed in Croatia and it is registered for treatment of positive and negative symptoms of schizophrenia. However, literature data suggest that in clinical practice risperidone long-acting injection is also being used in treatment of different “off-label” conditions, such as schizoaffective disorder, bipolar affective disorder, psychotic episodes in personality disorders and behavioural disturbances associated with dementia [3]. Objective of this poster is to describe demographic and clinical features of acute psychiatric ward female patients, who were in everyday practice clinically estimated as suitable for risperidone long-acting injection treatment. Methods: Research included all patients treated with risperidone long-acting injection, in inpatient and outpatient setting of acute female ward of Psychiatric Hospital “Sveti Ivan” in Zagreb, Croatia, over time period of 4 years − from January 2007 to December 2010. Three different psychiatrists, who are permanently working on acute psychiatric ward since January 2007, have diagnosed and treated patients. Patients have been diagnosed by criteria of International Classification of Diseases (ICD), 10th revision. Data were collected by computerized search of digitalized medical records of Psychiatric Hospital “Sveti Ivan”. Summary of results: Research sample included 80 female patients. Presented demographic data include patients’ age, marital status, number of children, level of education, employment status, residency in rural or urban area and information about patients’ household arrangements. Presented clinical characteristics include diagnosis of psychiatric disorder, portion of patients experiencing first episode of disorder, information about presence of suicidal thoughts and attempts, formulation of previously prescribed
antipsychotic therapy, inpatient or outpatient status of patients at time when risperidone long-acting injection therapy was prescribed, prescribed doses of risperidone long-acting injection and information about presence of concomitant psychopharmacological therapy at time when risperidone long-acting injection was prescribed. Final results will be summarized at the end of July, when the research will be completed. Conclusions: Poster data represent overview of our clinical experience with risperidone long-acting injection in naturalistic setting of an acute female ward in psychiatric hospital, over period of 4 years. Presented data describe demographic and clinical features of patients who were considered to be suitable for risperidone long-acting injection treatment and who were expected to gain benefit from it. Results show that in every day clinical work risperidone long-acting injection is being used for treatment of several “off-label” conditions. References [1] Apiquian, R., C´ordoba, R., Louz˜a M., 2011 Clinical outcomes of longacting injectable risperidone in patients with schizophrenia: six-month follow-up from the Electronic Schizophrenia Treatment Adherence Registry in Latin America. Neuropsychiatric Disease and Treatment 7, 19−26. [2] Su, K.P., Chang, H.C., Tsai, S.J., Yen, F.C., Tang, C.H., 2009 Relapse and long-acting injectable risperidone: a 1-year mirror image study with a national claims database in Taiwan. Value Health 12:3, 118−21. [3] Stahl, S.M., 2008 Stahl’s Essential Psychopharmacology: neuroscientific basis and practical applications − 3rd ed. Cambridge University Press, 412−13.
P.3.c.049 Risk of adverse health outcome and metabolic syndrome in adolescents treated with antipsychotics: preliminary results J. Merch´an-Naranjo1 ° , M. Gir´aldez-Quiroga2 , C. Moreno1 , L. Pina1 , M. Parellada1 , C. Tapia1 , P. Rodr´ıguez1 , C. Arango1 . 1 Hospital General Universitario Gregorio Mara˜ no´ n, Child and Adolescent Psychiatry Department. Centro de Investigaci´on Biom´edica en Red de Salud Mental CIBERSAM, Madrid, Spain; 2 Hospital General Universitario Gregorio Mara˜ no´ n, Pharmacy Deparment, Madrid, Spain Background: In recent years, several studies have demonstrated that second-generation antipsychotics (SGAs) induce metabolic adverse effects (defined as metabolic syndrome), such as weight gain, dyslipidemia, and hyperglycemia, including new-onset type 2 diabetes mellitus, which contribute to cardiovascular disease among others. The aim of this study was to analyse the development of metabolic syndrome, defined as the presence of three of the following abnormalities: obesity with BMI 95th percentile, blood pressure > 90th percentile, triglyceride level > 110 mg/dL, HDL cholesterol level <40 mg/dL, and glucose level 110 mg/dL [1] and patients “at risk for adverse health outcome,” defined as BMI 95th percentile or BMI 85th percentile plus presence of one other obesity-related complication, i.e. hypertension, dyslipidaemia, or hyperglycaemia [2], [3]. These adverse effects, along with lifestyle and genetic predisposition, may contribute to shorter life expectancy in patients receiving SGA treatment compared with the general population. Methods: The patients enrolled in this study were drawn from a naturalistic longitudinal multicentre study conducted at four child and adolescent psychiatry units in Spain. The study sample was composed of 235 children and adolescents with any psychiatry diagnosis (mean age: 14.33±3.04 years, 141 males,
P.3.c. Psychotic disorders and antipsychotics − Antipsychotics (clinical) 88.51% Caucasian). Of those, 116 patients were antipsychoticna¨ıve (no prior treatment with antipsychotic) and 119 patients were quasi antipsychotic-na¨ıve (less than 30 days prior antipsychotic exposure) at the time of the baseline assessment. Treatments at baseline were as follows: risperidone (N = 75), olanzapine (N = 22), quetiapine (N = 17), haloperidol (N = 3), pimozide and chlorpromazine 1 patient, respectively. Patients were divided into three diagnostic groups: schizophrenia or any other disorder with psychotic symptoms (N = 93), bipolar disorder (N = 38), and other diagnosis (N = 104). At baseline and the 3, 6, and 12 month visits after baseline, we collected laboratory test results (glycosylated haemoglobin (HbA1c), insulin, insulin resistance, glucose, triglycerides, and cholesterol levels) and physical examination data (weight, height, Body Mass Index (BMI) (weight in kilograms/ height in meters squared [kg/m2 ]), and blood pressure (BP)). BMI was adjusted for age and gender by conversion to a z-score with Spanish normative charts. A descriptive analysis was performed using SPSS 16.0 (Windows version). Results: The number of children and adolescents at risk of developing metabolic syndrome at 3, 6, and 12 months was 21.97% (N = 40), 24.47% (N = 35), and 33.3% (N = 34), respectively. In addition, the number of patients who presented metabolic syndrome during the same period of time was 3.3% (N = 6), 6.29% (N = 9), and 6.86% (N = 7), respectively. Conclusions: The risk for adverse health outcome and development of metabolic syndrome appears after 3 months of antipsychotic treatment and it does not reverse, but rather increases during long-term treatment. These adverse events should be monitored in children and adolescent treated with antipsychotics throughout the entire treatment period. References [1] Cook S, Weitzman M, Auinger P, Nguyen M, Dietz W. 2003. Prevalence of a metabolic syndrome phenotype in adolescents: findings from the third National Health and Nutrition Examination Survey 1988–1994. Arch Pediatr Adolesc Med.; 157: 821−7. [2] Moreno C, Merch´an-Naranjo J, Alvarez M, Baeza I, Alda JA, Mart´ınezCantarero C, Parellada M, S´anchez B, de la Serna E, Gir´aldez M, Arango C. 2010. Metabolic effects of second-generation antipsychotics in bipolar youth: comparison with other psychotic and nonpsychotic diagnoses. Bipolar Disord. Mar; 12(2): 172−84. [3] Fraguas D, Merch´an-Naranjo J, Laita P, Parellada M, Moreno D, RuizSancho A, Cifuentes A, Gir´aldez M, Arango C. 2008. Metabolic and hormonal side effects in children and adolescents treated with secondgeneration antipsychotics. J Clin Psychiatry. Jul; 69(7): 1166−75. Disclosure statement: Supported by the Spanish Ministry of Health and Social Policy, Spanish Ministry of Science and Innovation, Instituto de Salud Carlos III, Centro de Investigaci´on Biom´edica en Red de Salud Mental, CIBERSAM, (Madrid, Spain). Dr. Arango has served as a consultant for to or has received honoraria from AstraZeneca, Bristol-Myers Squibb, Janssen-Cilag, Lundbeck, Otsuka, Pfizer, Roche, Servier, and ScheringPlough. AstraZeneca, Bristol-Myers Squibb, Fundaci´on Alicia Koplowitz, Fundaci´on Marcelino Bot´ın, Janssen, Pfizer, Schering-Plough, Servier, Spanish Ministry of Health and Spanish Ministry of Science and Innovation. Dr. Moreno has served as a consultant for Astra Zeneca, Bristol-Myers Squibb, and Otsuka. Dr. M. Parellada has received travel support from Astra-Zeneca and Juste. The rest of the authors declare no conflicts of interest.
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P.3.c.050 Antipsychotic monotherapy versus polypharmacy in patients with serious mental illness P. Ntounas1 ° , C. Tsopelas2 , A. Konsta3 , E. Rizos4 , A. Diakoumopoulou5 , P. Gkikas6 , E. Siouti1 , C. Touloumis1 , 1 Psychiatric Hospital of A. Douzenis4 , L. Lykouras4 . Attica, 10 th Dept of Psychiatry, Athens, Greece; 2 Psychiatric Hospital of Attica, 5 th Dept of Psychiatry, Athens, Greece; 3 Aristotle University of Thessaloniki Papageorgiou General Hospital, 1st Dept of Psychiatry, Thessaloniki, Greece; 4 National and Kapodistrian University of Athens Attikon General Hospital, 2 nd Dept of Psychiatry, Athens, Greece; 5 Psychiatric Hospital of Attica, 4 th Dept of Psychiatry, Athens, Greece; 6 Psychiatric Hospital of Attica, 6 th Dept of Psychiatry, Athens, Greece Objective: Monotherapy is recognized as the preferred mode of treatment, because it permits documenting patient’s response to an adequate trial of each medication, helping to reduce the complexity of the medication regimen, reducing the risk of adverse events, and making it easier to assess and manage future symptom exacerbations. Despite lack of endorsement by clinical treatment guidelines, the practice of antipsychotic polypharmacy continues to increase. A review of the literature finds that the overall point prevalence of antipsychotic polypharmacy ranges anywhere from 4.1% to 69%. In the literature there are case reports and open uncontrolled, nonrandomized trials, reporting increased incidence of serious adverse events such as hyperprolactinemia, akathisia, hypersalivation and even an increased risk of mortality when performing polypharmacy. Nowadays is accepted clinical practice the concurrent use of two or more antipsychotics in the hope that lower dosages of each agent may reduce the occurrence of adverse effects and/or that the combination may maintain or even enhance efficacy. The primary objective of this study was to compare monotherapy with polypharmacy in patients with serious mental disorder admitted in a big psychiatric hospital, regarding efficacy, compliance and presence of side effects for a 6 months follow up period. Methodology: 86 participants were randomly selected from a population of 1186 in-patients with diagnosis of schizophrenia, bipolar disorder, depression and other (substance abuse/general medical condition). Psychopathological assessment, carried out by 5 experienced adult psychiatrists, using the Structured Clinical Interview for DSM-IV axis-I disorders (SCID-I/P). Patients were assessed at baseline and at 3-monthly and 6-monthly intervals. Demographic data were obtained from patients medical chart. The SPSS statistical package was used throughout. Results: The sample consisted of 86 participants, 64% men, 36% women, mean age: 44.27 (sd = 10.1). The great majority had many admissions and 70.9% had diagnosis of Schizophrenia, 12.8% Bipolar disorder, 10.5% Depression and 5.8% other (Substance abuse/organic disease). 57% were on monotherapy and 43% were on two or more antipsychotics. Males were preferably on polypharmacy when compared to women (x2 = 3.9, df = 1, p 0.005) although there were not at baseline any differences in the severity of mental disorder, metabolic parameters, side effects and compliance. This lack of differences in compliance and lack of side effects (AST, ALT, g-GT, Blood Pressure, QTc, EPS, GLU tolerance, body weight differences) were maintainted thoughout the 6 months follow up, and there was also a tendency to consider monotherapy not effective (not statistically significant results). Conclusions: This study suggests that individuals with schizophrenia who are receiving two or even more antipsychotics, and