Pain is a complex experience that normally signals actual or potential tissue damage. Anticipatory anxiety to an unpredictable danger increases pain intensity and unpleasantness in healthy subjects. This study addressed the impact of anticipatory anxiety on pain perception in patients with chronic pain conditions for the first time.

28 female subjects with chronic pain (14 fibromyalgia (FM), 14 rheumatoid arthritis (RA)) and 14 age-matched healthy controls (HC) underwent differential Pavlovian delay conditioning. Conditioned stimuli included visual stimuli (simple black squares and triangles) and were paired with thermal stimuli of low temperatures (CS-), and in a pseudorandomized way in the other half of the trials with high (CS+paired) or low temperatures (CS+unpaired) of 6 sec duration. The conditioned response was measured by pain/anxiety self-rating and heart rate changes.

Subjects of the RA and HC, but not the FM group, rated the pain intensity of the same stimulus (low temperature) significantly higher in the unpredictable condition (CS+unpaired) than in the predictable condition (CS-). Mixed models analyses yielded a significant group-CS interaction with regard to anxiety, pain and heart rate in RA and HC, but not in FM

Results support impaired fear conditioning in FM including higher pain and anxiety perception even in save conditions compared to RA and HC. Since anxiety and anxiety-related behaviour may substantially contribute to the development and maintenance of chronic pain in FM, the results of this research may provide clues for further research in psychophysiology and psychological treatment in patients with FM.

The goal of the study was to analyze and compare the quality of life of patients with schizophrenia who live in rural and in urban districts.

Our group was randomly selected and consisted of 123 urban and 116 rural patients. We used standardized international mental health quality of life scale (QOL-36) questionnaire implemented by Phillip W. Long (2003). Statistical analysis was conducted with SPSS 16.0 program.

Social problems are equally common to both groups of respondents regardless their age and the length of the disease (p< 0,05). Professional - economic problems: 59% in districts, 91% in a city; insufficient income - 88% in districts, 69% in a city. Problems in sexual sphere were by 31% of urban patients and 77% of rural patients. Sleep disorders are bothering 34.6% of districts residents and 81% of city residents. The quality of life is estimated equally bad by the residents, despite their age and the duration of the disease.

The most frequent problems both in districts and in a city: unemployment, low income; cognitive disorders, physical fatigue, lack of interest/feelings; difficulties in communication with close friends. Problems are of different importance to urban and rural residents - sleep disorders (not important for rural residents), problems in sexual sphere (not important rural residents). The quality of life is estimated equally bad by the patients with schizophrenia, despite their age and the duration of the disease.

Correlational methods, unlike cluster analyses, cannot take into account the possibility that individuals score highly on more than one symptom dimension simultaneously. This may account for the inconsistency found in the correlates of schizotypy dimensions. This study explored the clustering of positive and negative schizotypy dimensions in nonclinical subjects and whether schizotypy clusters have meaningful patterns of adjustment in terms of psychopathology, social functioning, and personality.

Positive and negative schizotypy scores were derived from the Wisconsin Schizotypy Scales for 6.137 college students and submitted to cluster analysis. Of these, 780 completed the NEO-PI-R and Social Adjustment Scale-self report version, and further 430 were interviewed for schizophrenia-spectrum, mood, and substance use psychopathology.

Four clusters were yielded: low, high positive, high negative, and mixed (high positive and negative) schizotypy. The positive-schizotypy cluster presented more psychotic-like experiences and schizotypal and paranoid symptoms, had more affective and substance abuse pathology, and were more open and extraverted. The negative-schizotypy cluster had more negative and schizoid symptoms, worse social adjustment, high conscientiousness and low agreeableness. The mixed cluster was the most deviant on almost all aspects.

Our cluster solution is consistent with that of few previous cluster analyses in schizotypy and schizophrenia, indicating that meaningful profiles of schizotypy features are present in nonclinical populations. The clusters provide construct validity to the schizotypy types defined. The phenomenological similarity between schizotypy and schizophrenia in terms of their underlying dimensions and associated correlates in a general population sample supports the fully-dimensional conceptualization of schizotypy.

To explore a cognitive bias-Jumping to Conclusions-in patients with schizophrenia and to compare with non-psychotic siblings and healthy controls by means of the Picture Decision Task (PDT).

42 patients with schizophrenia, 20 non-psychotic siblings and 77 healthy controls were compared in the PCT. This task consists of showing drawings of common objects that are displayed on a computer screen in decreasing degrees of fragmentation: new features are added in eight successive stages, until the entire object is eventually manifest. There are two kinds of trials (“cued” and “uncued”; that is, with and without interpretative clues). According to the responses, five parameters were calculated: Jumping To Conclusions at first stage-that is, with the very first drawing-(JTC-1), Plausibility Rating at first stage (PR-1), Draws To Decision (DTD), Time Response at first stage (TR-1) and Time Response for Draw to Decision (TR-DTD)

In comparison with siblings and controls, more of the schizophrenia patients made a definitive decision at the first stage (represented by a significantly higher JTC-1), and they showed a higher Plausibility Rating (represented by a higher PR-1) than siblings and controls. For the uncued trials, patients needed fewer stages (a lower DTD) when making a decision than siblings (5.53±0.20 vs. 7.04±0.28; p=0.001) and controls (5.53±0.20 vs. 6.83±0.14; p=0.001).

These results suggest that patients make quick decisions with a high level of conviction and may manifest a data-gathering bias. Our results may indicate some degree of faulty appraisal and an inability to tolerate ambiguity when faced with decision-making.

This study assessed treatment compliance, effectiveness, tolerability and safety of oral second generation antipsychotics (oSGA) versus long-acting injectable risperidone (RLAI).

Non-interventional, 24-month study (RIS-SCH-4057) in schizophrenic patients (ICD-10 F20.x; CGI≤5) with monotherapy of oSGA (amisulpride, aripiprazole, olanzapine, quetiapine, ziprasidone, or risperidone) or RLAI.

Interim analysis after 12 months including 300 RLAI and 159 oSGA patients (ITT; m/f 48%/52%; age 42.1±11.5 years; mean disease duration 8.8±8.1 years). PANSS, CGI-C and SWN-K significantly improved in both groups (p< 0.001; no between-group differences). Compliance to study medication was 75-100% in >70% of both groups. In RLAI vs. oSGA patients retention rates were higher (54.0% vs. 43.3%; p=0.0542), retention time was 277±11 vs. 254±13 days (p=0.0995), relapse rate/patient/year was 0.15 vs. 0.21 and time to first relapse was 309±7 vs. 290±10 days (p=0.0485). Adverse events (AEs) were reported in 69.0% RLAI vs. 76.1% oSGA patients, serious AEs in 19.7% vs. 19.5%. One RLAI patient died with no causal relationship to study medication. Most common AEs at least possibly related to the study medication in RLAI vs. oSGA patients were fatigue (12.7% vs. 16.4%), disturbance in attention (12.7% vs. 13.8%), dry mouth (13.0% vs. 13.2%), weight increase (11.0% vs. 10.1%), and EPS (3.0% vs. 2.5%). 6.0% RLAI and 6.9% oSGA patients had serious AEs at least possibly related to the study medication.

The trend of these data towards lower relapse rates and longer retention with RLAI vs. oSGA indicates that RLAI therapy may help patients effectively to achieve better long-term outcomes.

This study aimed to assess:

1. a) the socio-demographic characteristics of patients with schizophrenia who were using cannabis at time of first appearing of psychotic symptoms;

2. b) the impact of cannabis on the duration of untreated psychosis (DUP) and on pathways to care;

3. c) the influence of cannabis on the clinical onset and on the first three years of the disorder.

Twenty-two patients with a recent onset (< 3 years) of schizophrenia were consequently recruited at the Department of Psychiatry of the University of Naples SUN. Socio-demographic characteristics, pathways to care and DUP were investigated by ad-hoc schedules.

About 60% of patients were using cannabis at onset of schizophrenia. All of them were male and did not have a job and with a lower education level. “Cannabis users” had a first contact with general practitioners earlier than “non cannabis users”, but their DUP was longer, as a consequence of significant delays in access to mental health care. Cannabis users showed higher rates of suicide attempts and relapses in the first three years, suggesting a more severe course of the disorder in the “critical period” of schizophrenia in this population.

The results of the study emphasize the need:

1. a) to carry out sensitization campaigns among young people in order to reduce the use of cannabis and other illicit drugs;

2. b) to promote information on schizophrenia for general practitioners.

Type 2 diabetes mellitus is more prevalent in patients with schizophrenia compared to the general population. However, there is a lack of evidence that co-morbidity with this and/or other physical diseases lead to excess mortality in schizophrenia. We investigated whether diabetes and other diseases are increased and are predictors of mortality in schizophrenia.

During 2000-2007, 679 patients with schizophrenia were admitted to University Hospital Birmingham NHS Trust, co-morbidities were compared with 88778 age- and gender group-matched hospital controls. Predictors of mortality were identified using logistic regression.

Type 2 diabetes mellitus was increased in schizophrenia compared to hospital controls (11.3 versus 6.3%). The prevalence of diabetes mellitus at first admission was higher in later deceased patients with schizophrenia (n=100, 24.0%) than those surviving (n=579, 9.2%). Predictors of mortality in schizophrenia were age (relative risk RR=1.1/year), type 2 diabetes mellitus (RR=2.2), pneumonia (RR=2.7), heart failure (RR=2.9) and chronic renal failure (RR=3.2). The impact of diabetes mellitus on mortality was significantly higher in schizophrenia than in hospital controls (RR=2.2 versus RR=1.1), deceased schizophrenics had more often suffered diabetes mellitus than deceased controls (10.5%).

Co-morbidity with diabetes mellitus is increased in schizophrenia in comparison with hospital controls; it also causes significant excess mortality in schizophrenia. Thus, monitoring for and prevention of type 2 diabetes mellitus is of utmost relevance in schizophrenia.

To estimate costs associated with medication non-adherence over a 3-year follow-up period in the treatment of schizophrenia in routine clinical practice in Europe.

SOHO is a 3-year, prospective, observational study of 10972 outpatient participants across 10 European countries. Data were collected at baseline and at 6-month intervals up to 36 months. Medication adherence was assessed at each visit by participating psychiatrists during 4 weeks prior to the visit as: (1) not prescribed medication; (2) always adherent; (3) partially adherent; and (4) never adherent. In this post-hoc analysis, multivariate analyses were performed to compare the costs of resource use (inpatient stay, day care, psychiatrist visits and medication) in patients who were adherent, partially adherent, and non-adherent, using a log-link function. Adherence status was included as a time-varying variable, and other baseline patient characteristics were adjusted for. UK unit costs were applied to resource use.

Out of 5364 patients who were prescribed medication prior to baseline, 5.9% were non-adherent while 77.1% and 17.0% were adherent and partially adherent, respectively, at baseline. The average 6-month cost incurred by non-adherent patients was £2505 while that for adherent and partially adherent patients was £2029 and £2130 respectively. This difference was mainly due to inpatient costs. The inpatient costs incurred by non-adherent patients (£987) were almost double those for adherent patients (£475).

Non-adherence in schizophrenia was likely to incur more inpatient services, which may indicate poorer clinical prognosis. A study limitation is that adherence was assessed by investigators using a single-item measure.

Akt1 gene has been associated with genetic etiology of schizophrenia (SCZ). SNPs and haplotypes with significant association were identified in different ethnic schizophrenia. In bipolar disorder (BD), these variants have not been studied. The aim of this study was to investigate the Akt variants both in SCZ and BD. We wished to determine whether the two disorders show similar patterns of association.

This case-control study included 788 subjects: 384 unrelated SCZ; 130 unrelated BD, and 274 unrelated healthy controls (HC) for six SNPs of the Akt1 gene located at the region spanning 36.9 kb. Genotyping was achieved with the HRM method and primers were designed by Primer3. Genotypic, allelic and haplotypic distribution between SCZ, BD and HC population were evaluated. Analyses were performed with Plink v.1.06.

The analysis identified a significant global distortion in SCZ (p< 0.0005) and a weak association in BD (p< 0.01). A four-SNP haplotype (TCGA) showed a significant association with SCZ (p< 0.0007) and BD (p< 0.006). This haplotype include the Emamian et al's core haplotype (3-SNP 2/3/4/, TCG). Intrestingly, SCZ and BD share this distorted haplotype. Other multi-SNP haplotypes also showed significant association with both diseases. No distortion was observed between SCZ and BD population, and when SCZ and BD were combined, the global p-value improved (p< 0.00005).

Our findings support the role of Akt1 in genetics of both SCZ and BD. The established association in both populations are consistent with the overlap model of theses nosologies.

It is well estabhished that the frequency of all types of personality disorders are increased in schizophrenia. Stable personality traits influence the progress of the illness. The aim of this study was to investigate comorbid personality disorders and their relations with positive and negative symptoms in schizophrenia patients.

Data belonging to 27 female and 23 male schizophrenic patients (n=50) followed-up in our outpatient clinic constituted our series. Any patients having a history of mental retardation, head injury, prior neurological illness, alchohol or substance abuse were excluded. All patients were in a clinically stable phase of illness, and having no changes in medication for at least three months. Having obtained informed consent, patients were administered the Structured Clinical Interview for DSM-IV (SCID) as well as the Scale for the Assessment of Negative Symptoms (SANS), Scale for the Assessment of Positive Symptoms (SAPS), Hamilton Axiety Scale (HAM-A), Calgary Depression Scale for Schizophrenia, Global Assessment of Functioning (GAF), and The Structured Clinical Interview for DSM III-R Axis II Personality Disorders.

Thirty-six schizophrenia patients had at least one kind of comorbid personality disorder (72%) while 14 (28%) had not. Comparing the patients having personality disorders to the rest of our patient population, we have found no statistically significant differences in age groups, clinical variables and functioning.

We have shown that approximately three fourths of our series accompanied by at least one type of personality disorders, a finding consolidating and concordant with some of the previous works.

To develop a toolkit (QuIRC) for assessing the living conditions, care and human rights of people with long term mental illness in psychiatric and social care facilities.

The QuIRC was developed by research partners across ten countries: UK; Germany; Spain; Czech Republic; Bulgaria; Italy; Netherlands; Poland; Greece and Portugal. Its content was informed by triangulation of the evidence on critical components of care collated from: a review of care standards in each country; an international literature review; and Delphi exercises with service users, carers, advocates and mental health professionals in each country. Its final format was agreed by an international panel of rehabilitation and recovery experts.

The toolkit includes 154 questions which assess seven domains of care provided in units for people with longer term mental health problems (living environment; therapeutic environment; treatments and interventions; self-management and autonomy; social inclusion; human rights; Recovery-orientated practice). It is completed by a senior clinician and takes around 90 minutes. Domain ratings can be used to assess and review the quality of care provided locally, regionally, nationally and internationally. A web-based version is under development that provides the unit with a report of its performance on these domains, compared to similar units in the same country. This will increase its accessibility for the review of care standard performance.

Schizophrenia is a brain disease that has distressed human kind since the beginning of the written history. Firm knowledge about this illness is limited to certain areas including cognitive, risk genes etc. Basic question remains unanswered about the diagnostic heterogeneity and tissue neurochemistry. Several lines of evidence focus on direct involvement of glutamergic system in the pathophysiology of psyhosis.

The pilot study measured the difference between the plasma serine recemase level of normal and schizophrenic patients and estimated the D-isomers excreted in the urine using gas chromatography and Gas chromatography and mass selectivity (GCMS) respectively.

Plasma and urine samples of normal and schizophrenic patients from UAE shows that the level of serine recemase and D-serine respectively is lower in schizophrenic pateints than that of the normal subjects.

The hypofunction of the glutamate N-methyl-D-Aspartate receptor (NMDAR) has been proposed as a model of schizophrenia in humans using molecular marker and also due to evidence suggesting modulation of glutamate cicuitries after antipyschotic administration. In this regard there is increasing evidence from pharmacological and genetic studies that suggest that D-serine an endogenous co agonist to the NMDA subtype glutamate receptor, may be implicated in schizophrenia (SCZ). Although an association of genes for D-serine degradation such as D-amino acid oxidase and G72 has been reported, a role of recemase in SCZ is unclear.

Collecting prospective data on medication adherence, course of illness, course of treatment, cost effectiveness and quality of life among patients with schizophrenia under the German health system.

The ELAN study was conducted as a multi-centre, non-interventional observation study. 374 patients with a diagnosis of schizophrenia or schizoaffective disorder (ICD-10 F2) who had been discharged with a medication of quetiapine (N=183), olanzapine (N=91) or risperidone (N=100) were included. Follow-up interviews were conducted after 6,12,18 and 24 months. Applied instruments comprised PANSS, MARS-S, EPS-M, AIMS-S, GAF, ZST and a questionnaire for quality of life.

For each follow-up, at least 80% of the original sample could be included. After two years, between 39% and 43% of patients continued to take the drug prescribed at discharge. Only between 4% and 7% of patients received no neuroleptic treatment in the last 6 months, respectively. The variety of drugs used increased during the course. Only small differences could be found regarding the defined outcome measures (PANSS, GAF, rehospitalisation rate) and side effects. Changes in medication were mostly due to insufficient efficacy or side effects. Doctor's recommendations had an important influence on patients’ decisions.

Under conditions of routine treatment, medication adherence was much greater and differences between drugs were smaller than reported in randomised controlled clinical trials. Taking into account the low sample selection bias and the small percentage of lost-to-follow-up subjects, this study provides some new insight into routine clinical treatment and outcomes in patients with schizophrenia.

Schizophrenia is the psychiatric disorder in which the awareness of pathology is most frequently altered. This merits particular attention, because related to medication compliance and clinical outcome.

To improve the level of insight in stabilized schizophrenia patients by means of two cognitive remediation techniques: Cognitive remediation program for patients with a schizophrenia spectrum disease - ReCoS and autobiographical memory program - RemAu.

The study is based on the results of neurocognitive and insight evaluations before and after treatment of two groups of ten patients with RemAu and twenty patients with ReCoS. The level of insight is evaluated using the SUMD and the PANSS scales. For cognitive capacity we test their concentration level (Trail Making Test, TMT, Stroop), executive functions (Wisconsin Card Sorting Test, WCST), memory (CVLT), autobiographical memory (TempAu) and their global cognitive capacity (WAIS III).

The results have enabled us to highlight the beneficial effects of the RemAu autobiographical reminiscence program on these patients’ insight. Although the ReCoS program does not significantly improve the level of insight, it produces results which are most satisfying with regard to the cognitive profile of each patient.

The patients who have most benefited from the program are those who already had a reasonable cognitive capacity before the treatment. This allows us to conclude that we should deliver a treatment which is directed simultaneously at persistent cognitive disorders and autobiographical memory in order to obtain optimal effect on the level of insight in this pathology.

To evaluate the striatal D3/D2 receptor occupancy of cariprazine (RGH-188) in healthy volunteers and schizophrenic patients, and assess the correlation between cariprazine plasma concentration and receptor occupancy.

Single- (0.5 mg) or multiple-dose (1 mg/day, 14 days) cariprazine was administered to healthy adult males (N=5) in an open-label positron emission tomography (PET) study. In a separate open-label PET study, multiple-dose cariprazine (0.5-3.0 mg/day, 14 days) was administered to adult male schizophrenic patients (N=8). Healthy volunteers had 1 predose and 1 postdose raclopride PET scan; schizophrenic patients had 1 predose and up to 3 postdose fallypride scans. Cariprazine plasma concentrations were determined by LC-MS/MS.

In healthy volunteers, single-dose cariprazine 0.5 mg resulted in low plasma concentration (0.1 ng/ml) and was associated with 12% maximum D3/D2 receptor occupancy; cariprazine 1 mg/day for 14 days resulted in cariprazine plasma concentrations of 2.3-3.4 ng/ml and >70% D3/D2 receptor occupancy. In schizophrenic patients, cariprazine 1.5 mg/day for 14 days resulted in cariprazine plasma concentrations of 2.5-3.4 ng/ml and >70% receptor occupancy; cariprazine 3.0 mg/day resulted in ≥90% occupancy. Predicted Emax values in schizophrenic patients approached 100% D3/D2 occupancy for dorsal and ventral striatum.

D3/D2 receptor occupancy in dorsal and ventral striatum was similar for cariprazine 1.0 mg/day in healthy volunteers and cariprazine 1.5 mg/day in schizophrenic patients. In both, higher receptor occupancy was associated with higher cariprazine plasma concentration. Cariprazine at 1.5 to 3.0 mg/day showed D3/D2 receptor occupancy within the predicted effective antipsychotic range.

There is a growing evidence that oxidative injury contributes to the patophysiology of schizophrenia (Sch), where higher concentrations of nitric oxide (NO) found to be neurotoxic. Data also suggest that bilirubin (BR) can serve as an endogenous scavenger of NO. The aim of this pilot study was to compare the serum levels of BR and NO among patients suffering from Sch, as well as to estimate whether NO serum levels differ between patients and healthy controls.

The study population were consisted of inpatients (n=20) who met DSM-IV diagnostic criteria for Sch confirmed by Structured Clinical Interview (SCID 1) and healthy controls (n=20). In order to exclude psychiatric morbidity in control subjects the same diagnostic procedure was applied. Serum BR levels were measured by the method of Ehrlich. NO concentration in serum was determined by classic colorimetric Griess reaction

In patients with schizophrenia BR serum level were 9.85±1.182 mmol/L ; X±SEM. Serum NO level was significantly higher in patients with Sch (23, 26 ± 1, 76 μmol/L; X±SEM) than in control subjects (14, 36±1, 42 μmol/L; X±SEM, p=0.001). Correlation between serum nitric oxide and BR values were 0.1518.

Results of this study reveal that BR plays possible protective role in NO cell toxic activity. Our finding of increased serum NO levels in patients with Sch indicates its potential role in pathophysiology of this severe psychiatric disorder. However, those results are preliminary and have to be confirmed in sample of larger size.

For the studies, we have used 225 patients from Children's Psychiatric Hospital. 82 of all selection were with schizophrenia spectrum disorders, 27 patients with affective disorders and 116 patients came from control group.

Patients were selected according to their diagnosis (in line with ICD-10) and current clinical status. Each diagnosis and clinical status was coded depending on its severity and course of disease.

The level of Hcy was stated by isocratic HPLC system with fluorometric detection (Shimadzu LC-20, model RF-10AxL).

Correlation of Hcy concentration between schizophrenia's spectrum disorders and control group was r = -0.39 (p< 0.001; t = 22.99).

Mean level of Hcy was 11.94 μmol/L for patients with schizophrenia's spectrum disorders and 11.55 μmol/L for patients with affective disorders versus 7.47 μmol/L in control.

It has been found that the highest level of Hcy in the group of schizophrenia spectrum disorders has been seen in patients with episodic-recurrent course of disease, especially with pronounced affect. For the group with affective disorders the highest level was seen in patients with depressive symptoms with anxiety and mixed affective disorders (r = 0.58; p< 0.001; t = 12.77).

Obtained data are indicative of potential link among the level of Hcy and schizophrenia, and that the level of Hcy is inwrought with affective disorders and anxiety in the course of disease.

To test in first-episode schizophrenia (FES) patients whether early treatment improvement accurately predicts subsequent treatment outcome and to develop a valid definition for early improvement.

188 first episode schizophrenia inpatients were assessed with the Positive and Negative Syndrome Scale (PANSS) at admission and biweekly until discharge within a randomized, double-blind trial. 93 patients were treated with risperidone, 95 with haloperidol. Response was defined as a 40% improvement in PANSS total score from admission to discharge, remission according to the recently proposed consensus criteria and early improvement as an improvement in the PANSS total subscore after the second week. Receiver operator characteristic (ROC) analyses were used to evaluate predictive validity of early improvement and to find the most reasonable cutoff definition according to specificity and sensitivity. A confidence interval for the optimum cutoff was furthermore estimated.

ROC analyses revealed reasonable predictability for response (AUC=0.707) and remission (AUC=0.692) concerning early improvement as a predictor for response/remission. No significant differences were found between the two treatment groups. Early improvement defined as a 46% PANSS total score reduction for response and a PANSS total score reduction of 50% for remission obtained the best results in terms of sensitivity and specificity.

We were able to confirm that early improvement is a valid predictor of subsequent treatment response and remission. FES patients should at least improve up to 30% in the PANSS total score at week 2 to achieve treatment response and remission.

Asenapine is indicated in adults for acute treatment of schizophrenia and bipolar I disorder. Here, the long-term safety and efficacy of asenapine versus olanzapine is described in schizophrenia and schizoaffective disorder patients treated for up to 3 years.

In a 1-year core study, patients were randomized to double-blind treatment with asenapine (5 or 10 mg BID) or olanzapine (10-20 mg QD). Patients completing the core study, and willing to continue treatment, received up to an additional 2 years of double-blind treatment. Safety evaluations assessments included adverse events (AEs), vital signs, body weight, and extrapyramidal symptoms (EPS). Efficacy, changes in Positive and Negative Syndrome Scale (PANSS) total score, was evaluated in the intent-to-treat population using observed cases.

In 440 enrolled patients (asenapine, 290; olanzapine, 150), the mean±SD daily dose was 13.4±4.1 mg for both asenapine and olanzapine; total exposure duration (including core study exposure) was 676.3±148.1 and 692.5±140.7 days for asenapine and olanzapine, respectively. Mean weight gain was 1.6 kg with asenapine and 5.0 kg with olanzapine; incidence of clinically significant weight gain was 28% and 40%, respectively. Incidence of EPS-related AEs was 4.5% with asenapine and 3.3% with olanzapine. AEs occurring in ≥10% of patients treated for up to 3 years will be listed. Mean±SD changes in PANSS total score over the course of the extension study were 1.7±11.0 with asenapine and -0.8±9.5 with olanzapine.

Asenapine and olanzapine were well tolerated and maintained efficacy in patients receiving up to 3 years of treatment.