Extrait

Background and study aims The human body has an internal system known as the endocannabinoid system which regulates processes within the body. The purpose of this study is to find out how the endocannabinoid system can affect brain function and symptoms experienced by people in an ‘at-risk mental state’, who may experience psychological problems or difficulties in coping with day-to-day activities. We will do this by assessing the effects of a chemical known as cannabidiol (CBD) on symptoms and brain function using Magnetic Resonance Imaging (MRI) brain scans. Cannabidiol is a cannabinoid that is extracted from the cannabis plant and is known to affect the endocannabinoid system. It is not responsible for the acute effects produced by cannabis, such as ‘feeling high’. Based on published information, it appears that CBD may have certain beneficial psychological effects. We hope that in the future, the knowledge gained from this study will help in a better understanding of the causes of mental health problems and in the development of new treatments. Who can participate? Right-handed adults aged 18-35 who are ultra-high risk (UHR) for psychosis. What does the study involve? Participants are randomly allocated to one of two groups. Those in the first group are given capsules containing 600mg of cannabidiol to take once a day for 21 days. Those in the second group are given capsules containing a placebo (dummy drug) to take once a day for 21 days. At the start of the study and then again after 21 days, participants in both groups have an MRI scan of their brain and have a sample of blood taken to measure levels of endocannabinoid substances in the body. What are the possible benefits and risks of participating? Participants may benefit from an improvement to their mental health problems, however this is not guaranteed. There is a small risk of some mild sleepiness but otherwise no other side effects have been reported from taking the study drug. There is a risk that some participants may feel anxious or claustrophobic during MRI scanning, and there is a small risk of some temporary, mild discomfort and bruising when having blood samples taken. Where is the study run from? The study is run from the Department of Psychosis Studies at the Institute of Psychiatry, Psychology and Neuroscience, King’s College, London (UK) When is the study starting and how long is it expected to run for? April 2012 to February 2017 Who is funding the study? Medical Research Council (UK) Who is the main contact? Dr Sagnik Bhattacharyya

Critère d'inclusion

• Ultra High Risk for Psychosis

Liens

• isrctn