One of the most important critical decision to be taken when designing a randomized controlled trial (RCT) in clinical psychopharmacology is the choice of the comparator. This choice is crucial because it affects many issues related to both internal and external validity. The aim of a RCT may be to establish efficacy in absolute terms, against an inert treatment (usually a placebo), or to establish efficacy with respect to another treatment (also known as comparator), a trial may be designed to demonstrate that the new drug is superior to the control intervention or, by contrast, that the new drug is similar to the control intervention in terms of, say, symptoms' reduction. Three kinds of RCTs may be designed: Superiority trials, Equivalence studies, Non-inferiority studies.

Background – As a large number of persons are exposed to prescribed psychotropic drugs, their utilisation and impact should be further explored at the population level. Aims – To illustrate the interest of pharmacoepidemiological studies of psychotropic drugs by selected examples of major public health issues. Method – Selective review of the literature. Results – Many questions remain unsolved regarding the behavioural teratogenicity of prenatal exposure to psychotropic drugs, the impact of their increasing use in children, the long-term cognitive consequences of exposure to benzodiazepines, and the risks associated with extension of indications of antipsychotic drugs. Conclusion – Pharmacoepidemiological studies need to be further developed owing to the large number of public health questions raised by the extensive and expanding use of psychotropic drugs.

This editorial reflects on current methodological trends in translational research in mental health. It aims to build a bridge between two fields that are frequently siloed off from each other: interventional research and phenomenologically informed research. Recent years have witnessed a revival of phenomenological approaches in mental health, often – but not only – as a means of connecting the subjective character of experience with neurobiological explanatory accounts of illness. Rich phenomenological knowledge accrued in schizophrenia, and wider psychosis research, has opened up new opportunities for improving prediction, early detection, diagnosis, prognostic stratification, treatment and ethics of care. Novel qualitative studies of delusions and hallucinations have challenged longstanding assumptions about their nature and meaning, uncovering highly complex subjective dimensions that are not adequately captured by quantitative methodologies. Interdisciplinary and participatory research efforts, informed by phenomenological insights, have prompted revisions of pre-established narratives of mental disorder dominated by a dysfunction framework and by researcher-centric outcome measures. Despite these recent advances, there has been relatively little effort to integrate and translate phenomenological insights across applied clinical research, with the goal of producing more meaningful, patient-valued results. It is our contention that phenomenological psychopathology – as the basic science of psychiatry – represents an important methodology for advancing evidence-based practices in mental health, and ultimately improving real-world outcomes. Setting this project into motion requires a greater emphasis on subjectivity and the structures of experience, more attention to the quality and patient-centredness of outcome measures, and the identification of treatment targets that matter most to patients.

Aims – To describe what users with schizophrenia think about the causes of their disorder. Methods – In each of the 10 participating Italian mental health centres, 25 users with schizophrenia were consecutively recruited and asked to complete the Users' Opinions Questionnaire (UOQ). Results – 150 out of 198 respondents mentioned at least one social cause for their mental disorder, and 114 reported exclusively social causes. Family conflicts were the most frequently reported social cause (21%), followed by traumas (20%), work and study difficulties (17%), and psychological disturbances (17%). Ten percent of the respondents mentioned biological causes. Biological causes were more frequently reported by users who were aware of their diagnosis of schizophrenia, whereas social causes by those who just knew they suffered from a psychosis. Difficulties in social relationships were more frequently pointed out by respondents with an earlier onset of the illness and a higher number of compulsory admissions in the previous 12 months. These users expressed more scepticism about the usefulness of the treatments they received, and perceived a greater social distance. Conclusions – Users' beliefs about the causes of their disorder should be taken into account by psychiatrists in order to improve their working alliance with them.

Declaration of Interest: None of the authors has had any interest or he/she has received any form of support, including that from drug companies and honoraria for lectures and consultancies, potentially in conflict with this scientific work. None of the authors has received any form of fee for his/her participation in this study. This study was supported by a grant received from the “M. Lugli” Foundation (grant no. 2–18–8).

Aims – Psychiatric patients often are not informed about their diagnosis and their involvement in the decision making process is rare. Aim of the study was to explore the informative needs of patients with schizophrenia and the knowledge about their illness. Method – Three focus groups were conducted with 25 long-stay patients with the diagnosis of schizophrenia, attending the Mental Health Centre of the South-Verona Community-based Mental Health Service. The group discussions were audiotaped and transcribed. Results – The authors identified 18 different thematic categories which were used by two raters to classify all patient contributions. The interrater reliability was satisfactory. The qualitative analysis evidenced that patients have little knowledge about their illness. Patients had confuse and vague ideas on schizophrenia but their knowledge on drug names, dosages and side effects appeared precise and detailed. Several patients have looked for information in encyclopedias and medical dictionaries. Conclusion – The findings suggest a need of patients affected by schizophrenia for an information exchange with their psychiatrists that takes into account their informative needs, corrects wrong beliefs and actively involves them in therapeutic decisions.

Aims – Psychiatric hospitals remain the main venue for long-term mental health care and, despite widespread closures and downsizing, no country that built asylums in the last century has done away with them entirely – with the recent exception of Italy. Differentiated community-based residential alternatives have been developed over the past decades, with staffing levels that range from full-time professional, to daytime only, to part-time/on-call. Methods – This paper reviews the characteristics of community-based psychiatric residential care facilities as an alternative to long-term care in psychiatric hospitals. It describes five factors decision makers should consider: 1. number of residential places needed; 2. staffing levels; 3. physical setting; 4. programming; and 5. governance and financing. Results – In Italy, facilities with full-time professional staff have been developed since the mid-1990s to accommodate the last cohorts of patients discharged from psychiatric hospitals. In the United Kingdom, experiments with hostel wards since the 1980s have shown that home-like, small-scale facilities with intensive treatment and rehabilitation programming can be effective for the most difficult-to-place patients. More recently in Australia, Community Care Units (CCUs) have been applying this concept. In the Canadian province of British Columbia (BC), Tertiary Psychiatric Residential Facilities (TPRFs) have been developed as part of an effort to regionalise health and social services and downsize and ultimately close its only psychiatric hospital. Conclusions – This type of service must be further developed in addition to the need for forensic, acute-care and intermediate-level beds, as well as for community-based care such as assertive community treatment and intensive case management. All these types of services, together with long-term community-based residential care, constitute the elements of a balanced mental health care system. As part of a region's balanced mental health care plan, these Tertiary Psychiatric Care Facilities have the potential to act as hubs of expertise not only for treatment, rehabilitation, community integration and ser-vice co-ordination for the severely mentally ill, but also for research and training.

Declaration of Interest: None.

This study is aimed at the importance of social care in rehabilitation. A brief overview of the social care theme is used as the methodology. There is a tension in mental health care between biological and psychological treatments that focus on deficits at the individual level (symptoms, disabilities) and social interventions that try to address local inequalities and barriers in order to improve access for service users to ordinary housing, employment and leisure opportunities. The history of mental health care tells us that social care is often underfunded and too easily dismissed as not the business of health care. But too much emphasis on a health model of individual deficits is a slippery slope to institutionalisation by way of therapeutic nihilism. Rehabilitation services follow the biopsychosocial model but with a shift in emphasis, recognising the vital role played by social interventions in improving the functional outcomes that matter to service users including access to housing, occupation, leisure facilities and the support of family and friends. In conclusion, rehabilitation is framed within a model of personal recovery in which the target of intervention is to boost hope and help the individual find a meaning to life, living well regardless of enduring symptoms.

Aims — Description of students' opinions about schizophrenia and depression. Methods — The study was carried out on a sample of 445 secondary school students, randomly allocated to a “schizophrenia” or a “depression” group (N=221 and N=224, respectively). Each respondent was asked to read a case—vignette describing a case of schizophrenia or depression, and then to fill the Questionnaire on the Opinions about Mental Illness — General Population's version (QO—GP). Results — 35% of students in “schizophrenia” group vs. 85% in “depression” group attributed a correct diagnosis to case—vignette. 19% of students in the “schizophrenia” group vs. 39% in the “depression” group believed that these mental disorders can recover. Affective and civil rights were more frequently acknowledged to patients with depression than to those with schizophrenia. In both groups, the majority of students stated that mentally ill patients were unpredictable and socially dangerous. Students who reported TV stories on people with mentally ill were more frequently convinced on their unpredictability and social dangerousness. Conclusions — These results outline the need to: a) plan educational campaigns for students on mental disorders; b) alert media professionals on the impact that the way they present crimes committed by mentally ill patients may have on general population.

Declaration of Interest: None of the authors has had any interest or she has received any form of support, including that from drug companies and honoraria for lectures and consultancies potentially in conflict with this scientific work in the last two years. None of the authors has received any form of fee for her participation in this study.

The corpus callosum (CC) is the brain's largest white matter tract, mostly composed by both myelinated and unmyelinated fibres, connecting the two cerebral hemispheres. The CC can be divided into different sections: rostrum, genu, body, isthmus and splenium (Aboitiz et al., 1992). Myelinated fibres predominate in the midbody and the splenium while unmyelinated fibres are more numerous in the rostrum and the genu. The callosal fiber disposition approximately reflects brain topography: the anterior sections connect the frontal lobes, the median sections connect temporal and parietal regions, and the posterior sections link occipital areas (Pandya et al., 1971). This traditional picture, however, which has been obtained mainly through studies in non-human primates has been partly modified by modern diffusion tensor imaging studies in humans (Hofer & Frahm, 2006). The CC matures after birth through adolescence and into early adulthood and is involved in different cognitive processes such as sensory-motor integration, attention, language, arousal and memory. Its size has been shown to be associated with handedness, sex (i.e., greater splenium in females and greater genu in males, Dubb et al., 2003) and cerebral laterality (i.e., inverse correlation between callosal connectivity and brain lateralization in males; Luders et al., 2003), and age (Ota et al., 2006) Specifically, age-related callosal degeneration has been detected by a diffusion tensor imaging (DTI) study (Ota et al., 2006) in the sub-regions that connect areas which are thought to be vulnerable to normal aging: the genu, rostral body, and isthmus. This result replicated post mortem findings of callosal degeneration in rostral body, anterior midbody and isthmus (Aboitiz et al., 1996).

Objective — The implementation of a simple methodology to estimate full costs of services provided by a public mental health centre. Setting. CPS (NHS Mental Centre) Ussl 35, Magenta, Lombardy Region. Method — To estimate full costs of 16 types of service we followed a two step procedure. The first step was to estimate all costs attributable to the CPS. In the second one, we allocated this estimate to each type of service provided. We attributed to the CPS the following cost items: personnel, utilities (telephone, electricity, water, heating and cleaning), land & building, transports (for services provided outside the clinic) and a share of general cost of the USSL to which the CPS belongs. Full cost of each service was then calculated on the base of the yearly number of services provided and the time spent by each health professional. Results — In 1995, the CPS provided 14, 562 services. Total costs amounted to L 1,356 million, and more than three quarters of this amount was attributable to the personnel working at the CPS. Unit costs ranged from L 5,300 (drug administration) to L 442,400 (family therapy involving two professionals for 90 minutes) The unit cost of psychiatric visits, psychologist consultations and nurse domiciliary visits were L 105,300, L 106,600 and L 78,000, respectively. Conclusions — This approach requires accessible data and is relatively simple to manage. Some refinements are required, especially to improve the methodology for the determination and the allocation of overheads. However, we are convinced that this cost accounting procedure provides acceptable estimates of the services provided by the CPS. These estimates suggest that charges to be used to fund NHS providers may be too low, especially if fee-for-service will be the main funding source.

Having first introduced the pragmatic health care trial, the discussion then focuses on a selected list of technical problems that are important for the design, analysis and inference from such trials. The first is lack of independence of participants’ outcomes do to clustering either arising from a cluster randomized design or to the way treatment is delivered (therapist and group effects). The second and third concern the implications of non-adherence to treatment and subsequent loss to follow-up, particularly, when non-adherence is associated with missing outcome data. Finally, it is argued that pragmatism and a desire for a scientific explanation should not be regarded as mutually exclusive.

The new WHO World Health Report on Mental Health includes a comprehensive and updated assessment of the current mental health situation at the global level, a critical and well-documented reflexion on the progresses achieved and the failures registered in global mental health, and an indication of the paths and strategies that should be prioritised to ensure the transformations that are urgently needed. The report offers significant enrichments on different areas like social determinants, premature mortality of persons suffering from mental disability, the negative aspects of the persistence of inpatient institutions, the role of people with lived experience as important agents of change, the importance of child and adolescent mental health. The present Editorial stresses the importance of Deinstitutionalisation as a cross-cutting element of all health policy, plans, budgeting and service organisation and draws attention to the fact that the ubiquitous persistence of large psychiatric institutions is a clear indicator that reality is far from declarations despite the UN Convention on the Rights of Persons with Disability.