Clozapine is uniquely effective in the management of treatment-refractory psychosis. However, many patients who are eligible to receive clozapine do not receive it, either because they have previously experienced adverse effects, or because of a reluctance to undergoing mandatory blood monitoring. At the National Psychosis Unit, a service designed for patients with treatment refractory psychosis, we specialise in helping patients to start to re-start clozapine under these circumstances. This presentation will combine research evidence and our own experience on the National Psychosis Unit to offer advice on improving the acceptability and tolerability of clozapine. I will cover common but troublesome problems such as hypersalivation and sedation, as well as the approach to re-challenging patients who have previously experienced suspected blood dyscrasias or cardiovascular complications of clozapine.

The general objective of the SUPREME project is to promote mental health in adolescents through the development and evaluation of an internet based, multi-language, culturally adapted, mental health promotion and suicide prevention intervention. The intervention will be designed building up on previous work done in the field. Existing interventions will be mapped and reviewed through a literature review and direct search on the Internet. A partnership of experts will be developed in order to ensure the highest quality scientific standards. The intervention will comprise a highly interactive website targeted at adolescents and young adults in the age group 14–24. The intervention will be translated and culturally adapted for all countries participating in the SUPREME project. On the basis of the results guidelines will be issued for best practices in the field of internet and media usage for mental health promotion interventions.

The main intervention of the SUPREME study is a website aimed at mental health promotion and prevention of mental Ill-health and suicide. Different website components are designed to achieve these goals using interractive as well as static information delivery techniques, peer to peer communication platforms, help-lines based on professionals.

Information regarding mental health problems such as depression, anxiety, psychoses, and stress are delivered through a set of interlinked webpages, which is also designed to provide contact information for local health services, hotlines.

An interractive module provides information based on the Awareness Program designed to promote knowledge of mental health, healthy lifestyles and behaviors among adolescents through virtual role-play and other interactive elements.

In a mental health monitor module, users may choose to fill out any of a large set of questionnaires related to mental health, and risk-behaviors and thus track their own mental health and received specifically tailored advice on help-seeking and coping strategies.

A web-based chat module provides an opportunity for adolescents to establish a direct text-based communication with mental health professionals.

A platform aimed at involving young people in mental health promotion, allows users to submit ideas regarding projects, actions, or for instance suggestions for health care related improvements. These ideas are reviewed by professionals who provide feedback, and assist these active adolescents in materializing their suggestions. An moderated discussion forum is aimed at generating discussions about mental health, sharing experiences and learning about the topic from professionals.

The presentation will give an overview of the Estonian language websites that users are likely to find when seeking suicide related information on the web. The material for the study was collected within the EC Public Health Programme project SUPREME (Suicide Prevention by Internet and Media Based Mental Health Promotion).

Sixty search hits were examined using the Google search engine on two different keywords referring to suicide (in Estonian language ‘suitsiid’ and ‘enesetapp’). Research method was qualitative thematic content analysis. The following five content categories were revealed: statistics about suicide; suicide provoking and stigmatisation; suicide prevention and help for persons in suicidal crisis; neutral informative materials; professional advice.

The conclusions based on the results were: the websites of organisations aiming to prevent suicides should include clear guidelines where to refer in case of depression and suicidal thoughts; when developing a website, the strategy for making websites easily available in search engines should be carefully elaborated; the websites that avoid stigma and offer help should open first, when a suicidal person uses in search engines the keywords like suicide and depression; web-based forums should not be un-moderated discussion groups, especially those targeted to adolescents and youth.

There is no health without mental health. This WHO slogan symbolizes that that any health promotion should include mental health components. It is evident that effective mental health promotion techniques are successful in increasing improved mental health and well-being among adolescents. Research has demonstrated that the Internet and the media are effective tools to disseminate mental health information and education to adolescents; however, fundamental issues still remain in this procedure. If used improperly, the information disseminated on the Internet can result in serious detrimental consequences on adolescents’ mental health and well-being. On the other hand, if the information is supportive, informative and educational, the effects can be positive. Many adolescents that suffer from social isolation reach out on the Internet as a way to cope with feelings of loneliness and social exclusion. Therefore, there is a unique opportunity to utilize the Internet as a means of communication to reach vulnerable adolescents who suffer from social exclusion, in which cases otherwise go undetected. Moreover, given that Europe, as a whole, is an extensive multicultural environment, requires considerable thought in preparing and adapting culturally-specific interventions that can be implemented in each respective European country. For this reason, resources used in a mental health intervention across Europe necessitate a culturally diverse partnership for materials to be translated and culturally adapted to the respective European region or area.

The purpose of this discussion is to explore academics’ views on the use of reliability as a vital element to clinical trials and research. The main research question guiding this investigation is “How do academics approach the understanding of reliability as a resource in their courses and research studies?” There have been several recent attempts to use more advanced statistical analysis to judge reliability in clinical trials (including, bayesian methods, item response analysis, generalizability theory), however these methods of reliability are rarely discussed in academia, and are not commonly utilized in clinical trials. The common texts used in teaching reliability are The Standards for Educational and Psychological Testing (AERA et al., 1985), and Cronbach's reliability (1990); both of which expound reliability as a necessary, although insufficient, condition for validity, and both of which primarily discuss reliability from an educational testing perspective rather than in clinical trials. Because power and other features depend heavily on the reliability of the measures employed, so also should the reliability coefficient of study measures be reported in clinical trials. This would prompt a deeper understanding by academics, authors and readers for potential factors that could explain negative results, or a discrepancy between results from different studies. This would also allow subsequent academic and clinical researchers to better explain the reliability of measures in the design of future studies.

One principal characteristic of an outcome measure in a clinical trial is reliability. The reliability of a measurement is an important consideration in the choice of the outcome measure for a clinical trial and in the choice of measures used for eligibility and exclusion. Just as the power of a study is reported in a final publication, so also should the reliability of the outcome and eligibility measurements so as to allow the authors to better describe, and readers to better understand, the sources of imprecision in study results, and to improve the design of future trials. The precision of measurements will be discussed, as the lower the precision, the more subjects will be needed for the clinical trial, which can affect outcomes and increase cost. The speaker will address the main components of measurement error, including systematic bias (general learning or fatigue effects), and random error due to biological or mechanical variation (including administration of study efficacy measures). In a clinical trial, error components should be meaningfully quantified for the researcher and physician to relate the described error to judgments regarding analytical goals (rather than just the statistical significance of the reliability indicators). Researchers should be cautious in (1) concluding acceptable reliability even if a correlation is high; (2) extrapolating the results of to a new sample; and (3) comparing reliability results between studies.

The FDA, EMA and MRHA draft guidance of late 2011 recommends the adoption of more risk-based methods by sponsors to monitor clinical investigations. In neuroscience trials, the data verification and site monitoring process is effective in confirming adherence to good clinical practices and adherence to the protocol guidelines; however, does not adequately assess the actual quality of the outcome measure data from a clinical perspective and, too often, does not account for serious protocol deviations in a timely manner. This session discusses data driven risk-based quality control methods currently utilized in neuroscience clinical trials to determine the quality of outcome measure data. In this session, participants will learn how robust data monitoring platforms and sophisticated analytics ensure that emerging risk signals are identified early, addressed in a consistent way, and corrected in a timely manner.

An inadequate sample size, low statistical power and poor reliability in a clinical trial exposes subjects to potentially harmful treatments without advancing knowledge. An unnecessary number of subjects may be exposed to a potentially harmful treatment, or are denied a potentially beneficial one. For such an important issue, there is a surprisingly small amount of published literature. One step in determining statistical power and fidelity requires educing an effect size of scientific interest. From an industry viewpoint, it is not up to a statistician to decide this; however, it is the statistician's responsibility to try to extract this information from the industry researchers involved in planning the study. A major problem being observed is that researchers don’t recognize it as a question that they are responsible for answering. This presentation will outline a model of protocol fidelity in clinical trials. The model addresses the complexity of clinical trial research, by expanding the aspects of the research process that require attention to fidelity from more simple models focusing on delivery and performance that incorporates study design and training. This will allow a more precise understanding of the elements responsible for a treatment's success or failure, improving replicability and translation to clinical or community settings.