Extrait

Background and study aims Antipsychotics are the main medication of choice for treating mental illnesses such as psychosis and schizophrenia. How these medications are prescribed has remained relatively unchanged for over 50 years. Decisions regarding how much patients should take (the dose) are made without tests or objective clinical measures. Quite often, patients are prescribed the maximum licenced dose of their medication, and in some cases, even more. Monitoring the amount of medicine in the blood may help in decision-making regarding the amount of the drug that should be given, by helping to ensure that there is the right amount of medication, not too much or too little, for the individual person. This is because there is much variation in how different people’s bodies react to different doses. For example, smoking can affect how the human body reacts to drugs. Here, we want to investigate the use of drug levels in the blood for antipsychotics, otherwise known as therapeutic drug monitoring (TDM). This will help us to improve the techniques currently available and to work out which methods are acceptable to both patients and clinicians (such as doctors). We will also be working to try to ensure that the results are presented to clinicians in a way that is easy for them to access and understand. Who can participate? Patients aged 18-65 years from inpatient wards or outpatient clinical services, who are regularly prescribed olanzapine or risperidone (two types of antipsychotic drugs). What does the study involve? Participants have a clinical interview with a member of the research team. This includes questions about their current mental and physical health and their prescribed medication. A blood sample is taken up to a few days after the interview. The amount of antipsychotic drug in their blood is measured and the test w made available to their doctor/. The doctor may then decide whether or not the dose should be adjusted (increased or reduced). If the dose is adjusted, further blood tests may be suggested in order to check that the adjusted dose has in fact changed the level of the drug in the participant’s blood. Between four and eight weeks later, there will be another clinical interview and final blood sample taken. What are the possible benefits and risks of participating? As regards to benefits, there is a potential that the blood test results may help psychiatrists to better understand how an individual’s body is coping with the antipsychotic medication. This may then be used, in addition to other factors such as the severity of the illness, to allow for prescribing drugs tailored to each individual patient. The potential risks and/or disadvantages of participating include answering questions in the clinical interviews that may be sensitive or upsetting, some possible short-lasting discomfort and bruising from the blood test, and a possible delay in taking morning medication until after the research blood sample has been taken. Where is the study run from? The study was set up at the Institute of Psychiatry, King’s College London and is being run in the following NHS trusts: South London and Maudsley NHS foundation trust; Central and North West London NHS foundation trust; West London Mental Health NHS trust; South West London and St George’s Mental Health NHS trust; North Essex Partnership NHS foundation trust; and Barnet, Enfield and Haringey NHS trust. When is the study starting and how long is it expected to run for? December 2014 to May 2015 Who is funding the study? National Institute for Health Research (NIHR) (UK) - Clinician Scientist Fellowship Award Who is the main contact? Dr Maxine Patel

Critère d'inclusion

• Psychotic disorders

Liens

• ictrp
• isrctn