[Good clinical practice and the maintenance of ethical standards in medical research: advice for junior researchers working in mental health care]. / Good clinical practice en medisch-ethische toetsing: handvatten voor (beginnend) onderzoekers in de ggz.

BACKGROUND: In mental health care, more and more research is being done, particularly in the field of educational programmes. Unfortunately, junior researchers are often not fully informed about the rules and regulations relating to research and about medical ethics. Therefore, they are not in a position to make considered judgements that conform to good clinical practice and acceptable medical ethics.
AIM: To give practical advice to trainees, stimulating them to think carefully about ethical standards in patient-related research in mental health care. METHODS The article provides a practice-based overview of practical advice and ethical considerations.
RESULTS: We stress that before beginning their research, researchers should think very carefully about the ethics of medical research. Instructions and guidelines relating to medical and ethical standards are to be found in: directive for good clinical practice compiled by the central committee for human research (CCMO) with the accompanying e-learning module and in the basic course 'rules and organisation for clinical researchers' (BROK). Practical tips, illustrated with examples, provide a framework for stimulating thoughts on medical ethics. Finally, it is important to improve the ways in which research is embedded in the organisational structure of teaching programmes.
CONCLUSION: Basic information about GCP and the upholding of medical and ethical standards in patient-related research can be obtained from various sources. The main challenge is to ensure that GCP is firmly embedded in patient-related research undertaken by junior researchers.

[Depot antipsychotics in the year 2011]. / Depotantipsychotica anno 2011.

BACKGROUND: People suffering from a psychotic disorder show limited compliance with the prescribed regimen of antipsychotics. Insufficient compliance and insufficient insight into their illness are important contributing factors predicting recurrence of psychotic symptoms. AIM: To discuss what contribution long-acting, mainly intramuscular (depot) antipsychotics can make in reducing the chance of a psychotic relapse. Also, we suggest procedures for switching from oral to depot antipsychotics. METHOD: The currently available depot antipsychotics in the Netherlands are compared with each other, desired and undesired treatment effects are discussed. Also, the possible role of depot antipsychotics in limiting compliance problems is discussed. Expected developments in depot antipsychotics in the near future are presented. RESULTS: A review of the literature shows that there are insufficient studies supporting an evidence-based choice for oral versus depot antipsychotics in different clinical situations. A choice for depot antipsychotics does not solve all compliance problems, but it does make them manifest. CONCLUSION: The choice for oral or depot administration of an antipsychotic will have to be based on the patient's particular circumstances, including the medical history and insight in his/ her illness, risks to patients and others and the personal preferences of both patient and clinician. The choice for switching to depot antipsychotics in order to reduce compliance problems needs to be part of an overall treatment plan that includes psychosocial support.

What are the effects of antipsychotics on sexual dysfunctions and endocrine functioning?

The literature is reviewed and preliminary results of new studies are presented showing that treatment with classical antipsychotics, as well as risperidone, induces sexual dysfunctions in 30-60% of the patients. These antipsychotics also frequently induce amenorrhoea and galactorrhoea. Although comparative studies are rare, it is likely that prolactin-sparing antipsychotics, as recently shown in a randomized trial of olanzapine versus risperidone, induce less sexual side effects.From these studies, it becomes apparent that prolactin elevation induced by classical antipsychotics and risperidone is probably a factor in inducing sexual dysfunctions, amenorrhoea and galactorrhoea. The role of other factors inducing sexual dysfunctions like sedation, proportional, variant -blockade, testosterone, dopamine, and serotonin is discussed. Finally, it is concluded that sexual and hormonal effects of antipsychotics, although clearly important, are often neglected in research as in clinical practice. Lowering the dosage or switching to a prolactin-sparing antipsychotic often reduces sexual side effects, amenorrhoea, and galactorrhoea.