Evidence generation from healthcare databases: recommendations for managing change

There is an increasing reliance on databases of healthcare records for pharmacoepidemiology and other medical research, and such resources are often accessed over a long period of time so it is vital to consider the impact of changes in data, access methodology and the environment. The authors discuss change in communication and management, and provide a checklist of issues to consider for both database providers and users. The scope of the paper is database research, and changes are considered in relation to the three main components of database research: the data content itself, how it is accessed, and the support and tools needed to use the database. Copyright © 2016 John Wiley & Sons, Ltd.     

Agomelatine for Depression in Schizophrenia: A Case-Series

Objectives

Agomelatine, a melatonin (MT1/MT2) receptor agonist and 5-HT2C receptor antagonist, is a new antidepressant and a potential therapeutic option for major depressive episodes and negative symptoms in persons with schizophrenia. We investigated such treatment outcomes with respect to antidepressant efficacy, safety, and tolerability.

Methods

We report a consecutive case series of seven patients with schizophrenia and comorbid major depressive symptoms who received agomelatine for a period of at least six weeks in addition to stable doses of antipsychotic agents. General psychopathology, positive, negative and depressive symptoms were assessed with standardized interviews. Relevant blood parameters were assessed.

Results

Depressive symptoms improved significantly. Positive symptoms remained stable, while negative symptoms and global psychopathology improved significantly. Agomelatine was well tolerated in most patients.

Conclusions

Our findings provide initial evidence that agomelatine is safe and efficacious in treating depressive symptoms in patients with schizophrenia. Furthermore, agomelatine seems to be effective for the treatment of negative symptoms. Randomized controlled trials are necessary to confirm these first observations.     

The national healthcare system claims databases in France,SNIIRAM and EGB: Powerful tools for pharmacoepidemiology

The French health care system is based on universal coverage by one of several health care insurance plans. The SNIIRAM database merges anonymous information of reimbursed claims from all these plans, linked to the national hospital‐discharge summaries database system (PMSI) and the national death registry. It now covers 98.8% of the French population, over 66 million persons, from birth (or immigration) to death (or emigration), making it possibly the world's largest continuous homogeneous claims database. The database includes demographic data; health care encounters such as physician or paramedical visits, medicines, medical devices, and lab tests (without results); chronic medical conditions (ICD10 codes); hospitalisations with ICD10 codes for primary, linked and associated diagnoses, date and duration, procedures, diagnostic‐related groups, and cost coding; date but currently not cause of death. The power of the database is correlatively great, and its representativeness is near perfect, since it essentially includes the whole country's population. The main difficulty in using the database, beyond its sheer size and complexity, is the administrative process necessary to access it. Recent legislative advances are making this easier. EGB (Echantillon Généraliste de Bénéficiaires) is the 1/97th random permanent representative sample of SNIIRAM, with planned 20‐year longitudinal data (10 years at this time). Access time is 1 to 3 months, but its power is less (780 000 subjects). This is enough to study common issues with older drugs but may be limited for new products or rare events.     

The quest for developing new treatments from imaging techniques: promises,problems and future potential

Drug discovery and development in psychiatry is beset by many challenges, both those which are associated with the development process in general (and affecting all of medicine) and others, which are unique to psychiatry. Due to these factors, marginal progress has been achieved in the past as many features of serious mental illness remain untouched by existing treatments. Arguably, the most important of these drug targets is cognitive dysfunction, which strongly predicts clinical outcome in a number of major neuropsychiatric conditions. Therefore, a critical need exists for progress in the characterization of this and other targets for drug discovery and development. A key area, which is already showing promise, is the use of non-invasive functional neuroimaging to investigate both cognitive dysfunction and its remediation with novel agents. In this article, the authors describe the paradigmatic case of cognitive dysfunction in schizophrenia, and the prospects for using functional magnetic resonance imaging (fMRI) to investigate the effects of agents targeting cognition. The authors observe a number of advantages of this approach over other methodologies, as well as some significant issues to be resolved in the application of this technology. The authors propose that pharmaco-fMRI is emerging as a major tool to enhance the drug development process in order to bring truly novel treatments to patients with a range of neuropsychiatric disorders.