Patients treated with olanzapine may experience substantial weight gain. This may result in metabolic abnormalities and contributes to lack of compliance. Recent findings indicate that the weight gain associated with Olanzapine is mediated by hypothalamic blockade of the Histamine H1 Receptor. Betahistine (Histalean™) is a centrally acting Histamine 1 receptor agonist used for the treatment of vertigo. We herein report the effect of Betahistine on Olanzapine induced weight gain.

To evaluate the safety, tolerability, pharmacokinetics of this drug combination.

48 healthy women were randomized in a double blinded manner to receive Betahistine 144 mg/day or matching placebo. One week later, all subjects began 3 weeks Olnazapine (7.5 mg or 10 mg/day) treatment period.

Overall the combined treatment was well tolerated. No difference was observed between treatment and placebo groups in adverse events rate or type. In the ITT population, the average weight gain in the Betahistine group was 1.2±1.3 Kg and 1.9 ± 0.9 Kg in the placebo group (p=0.0489). 52% of the placebo group gained more than 2.0 Kg versus only 23% in the treatment group (p= 0.043).

These results indicate that Betahistine is safe and effective in preventing Olanzapine associated weight gain.

[Absolute Weight change (kg) per visit, by Treatmen]

The effectiveness of electroconvulsive therapy (ECT) in pharmacotherapy resistant major depression and schizophrenia has been shown for all age groups. Nevertheless, age specific side effects such as greater cognitive impairment and higher somatic risks due to medical comorbidities and concomitant medication may be limiting factors in geriatric patients.

We retrospectively evaluated 4457 treatments in 380 patients. Clinical variables, treatment modalities, ictal and postictal neurophysiological parameters were analysed. For modelling the influence of age on these varibles of interest, linear regression models, if necessary logistic regression models, were performed (statistical software package R 2.8.1).

We found a considerable clinical improvement over all age groups. Higher severity of disease at admission came up with a better clinical response. In comparison of the whole patient sample versus the elderly over the age of 60, there were no significant differences in need and number of concomitant psychotropic, but in medical co-medication. Ictal and postictal EEG parameters were only in part predictive for clinical outcome, but age had a significant influence on most of them. Cardiovascular side effects and cognitive disturbances were more frequent in the elderly but were only transient, and in most cases there was no need for any specific treatment.

The outcome results show excellent effectiveness and tolerability of ECT in all age groups. The very old are more prone to adverse events, but nonetheless tolerate ECT well and are likely to benefit.

To compare treatment effects between AchEI (galantamine, GAL) and antipsychotics (risperidone, RIS) in patients with BPSD.

Open randomized trial in 100 patients (mean 78.7years, 67% females) using the NeuroPsychiatric Inventory score (NPI)>10 on patients (73% mild to moderate AD and 27% other dementias, treated with GAL (n=50) or RIS (n=50) for 12 weeks. Neuropsychiatric symptoms (NPI, CMAI, FAST), caregivers stress (PGWB), cognition (MMSE) and severity (CIBIC) were assessed at baseline and 12 weeks.

91 patients completed the trial. Safety and tolerability were good. 58% were APOEɛ4 carriers. At baseline MMSE was 20.1±4.6, and NPI 51.0±25.8. After 12 weeks NPI total scores had improved significantly (GAL: 16.6±16.1, RIS: 16.2±16.2).

In both groups there were statistically significant improvements after 12 weeks. In several of the NPI-domains galantamine and risperidone were equally effective. RIS showed a significant treatment advantage in the NPI-domains irritation (p=0.02), agitation (p=0.02) and a trend in aberrant motor behaviour (p=0.08). GAL showed a ppositive trend in apathy/indifference (p=0.09), night time behaviour (p=0.07) and appetite (p=0.06). GAL improved MMSE scores with 2.8 p (p< 0.001) and RIS with 1 p (p< 0.07).

This indicates that GAL could be beneficial in the treatment of neuropsychiatric and behavioural symptoms underlying AD unless aggressive symptoms are prominent.

Guidelines produced for management of Bipolar Disorder illustrate change in evidence-base for treatment of acute and maintenance phases of illness. Our Pan-European Research Group assessed clinical practice and desired treatments amongst amongst Psychiatry trainees.

A semi-structured survey was piloted, and homogenous sample size (at least 50) agreed upon from each country, with 50% minimum response rate. It was distributed via web-link, questioning preference of mood stabiliser for patients, trainees themselves and factors influencing choice.

Tables 1 summarise choices.

Factors influencing decision-making mapped onto cost, efficacy and side-effect profile (less than 4% other reasons). 66% (n=538) of respondents felt efficacy most important, 25% (n=202) felt side-effect profile most important and 3% (n=24) considered cost of most importance.

No clear difference exists in choice of mood stabiliser for European trainees and their patients, and decisions based on perceived efficacy are generally in keeping with established guidelines.

To assess in a naturalistic setting the effectiveness of olanzapine within 12-month follow-up, in schizophrenic and bipolar outpatients.In this abstract, baseline patient characteristics are provided and compared between the olanzapine coated (OC) and orally disintegrating (OD) formulations to investigate prescribing patterns.

ZEN is a 1-year prospective, observational study, carried out in France, Germany and Greece from April’07 to May’09. Baseline patient characteristics were compared using Students-t, Chi2 or Fisher's-exact tests. Patients who started olanzapine prior to 60 days before the study or for whom the olanzapine formulations could not be determined were excluded from the analysis.

903 of the 927 enrolled patients were analyzed (45.2% paranoid schizophrenia, 32.2% bipolar disorder). 410 patients received the OC form and 493 the OD form. Distribution of gender was comparable across groups (55.1% male).OC patients were older than OD patients (43.1 vs 39.1 years, p< 0.001) and had a longer mean duration of illness (14.4 vs 11.2 years; p< 0.001). OD patients were more severely ill irrespective of diagnosis (p< 0.006, mean CGI schizophrenia=4.2 vs 3.8, CGI bipolar disorder=4.1 vs 3.7). At initiation, daily dose in OD patients was higher (15.0 vs 10.6 mg, p< 0.0001). Based on the 6-level SUMD scale, more OC patients were clearly aware of having a mental disorder (44.7% vs 32.9%; p< 0.001). OC patients were more compliant at baseline (mean MARS score 6.6 vs 5.5, p< 0.001).

Baseline characteristics show that the utilization of each oral form of olanzapine in outpatient setting is associated with different patient profiles.

In the Federal Republic of Germany about 3 million people suffer from tinnitus/are hit by tinnitus, numerous of them depend on intensive medical care. The repetitive transcranial magnetic stimulation is considered to be an innovative and promising therapy in tinnitus treatment. Low frequency stimulation is meant to reduce the abnormal neural activity in the auditory cortex. This study focuses on the efficacy of rTMS with tinnitus patients in the course of a multi disciplinary / an interdisciplinary therapy concept.

From November 2008 to June 2009 29 outpatients with chronic tinnitus were treated by low frequency rTMS (1 Hz frequency, 2000 impulses, intensity 110%) for 10 proceedings, stimulating the sinistral auditory cortex with a figure-of-eight-coil. Prior to and afterwards the proceedings questionnaires and assessments of a psychologist took place, afterwards statistical analyses were conducted, the data was explored and systematically discussed.

The severity index of the tinnitus as well as the depression symptoms of the subjects improved significantly. The average reduction rate of the tinnitus score is set at 7 points. With a response criterion at the minimum of 5 points, 57% were declared as responder, 29% as non-responder and 4 patients (14%) described an increase of the tinnitus loudness/annoyance.

The results show that the rTMS works as a helpful treatment tool with tinnitus patients and should be considered as an option in the routine tinnitus treatment.

Body dysmorphic disorder (BDD) is characterized by a preoccupation with misperceived defects in appearance. Neuropsychological studies and neuroimaging studies of face perception suggests visual processing abnormalities in individuals with BDD, which may involve focus on details at the expense of configural elements.

The objective of the current functional magnetic resonance imaging (fMRI) study was to determine whether individuals with BDD have abnormal patterns of brain activation when visually processing non-face objects (houses).

Fourteen medication-free subjects with BDD and fourteen matched healthy controls engaged in a matching task of photographs of houses that were

1. a) unaltered,

2. b) high spatial frequency (high detail elements only), or

3. c) low spatial frequency (low detail elements only).

The main outcome measure was group differences in blood oxygen level-dependent fMRI signal changes.

BDD subjects demonstrated lesser activity relative to controls in left parahippocampal gyrus, left lingual gyrus, and bilateral precuneus for low spatial frequency images and relatively greater activity in the frontal pole, left superior frontal gyrus, bilateral anterior cingulate gyrus, and bilateral paracingulate gyrus for high spatial frequency images (Figure 1).

Individuals with BDD have abnormal brain activation patterns when viewing houses for both detailed and configural/holistic visual elements. These results suggest general abnormalities in higher- and lower-order visual processing in individuals with BDD, beyond that for appearance-related stimuli.

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.