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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Julia
Marcinkowska
julia.marcinkowska@kcl.ac.uk
Prof
Oliver
Howes
oliver.howes@kcl.ac.uk
Bernard
Bukala
synaptic-connectivity@kcl.ac.uk
Julia
Marcinkowska
synaptic-connectivity@kcl.ac.uk
Schizophrenia, schizotypal and delusional disorders
This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.
Mental health disorders are currently treated based on symptoms. Abnormality in nerve connections have been linked to mental illness especially in those where psychosis is present. Neurotransmitters are chemicals released in nerve junctions known as synapses and they help in their communication. One of the suggestions in subjects suffering from psychosis is that neurotransmission is impaired because the number of synapses (nerve junctions) present in the developing brain is less and the brain network is impaired. On the contrary in Autism spectrum disorder excess synapse formation has been suggested.
This study aims to vary neurotransmission by giving a drug called Levetiracetam (LEV) and record changes in brain function using brain scans. LEV binds to a protein called SV2A in the brain present in nerve junctions. We will use MRI and MEG brain scans. MRI uses the orientation of water molecules and blood flow to image the brain while MEG records magnetic fields generated in the brain. These scans will allow to understand the extent to which impaired brain network relates to impaired brain function in these disorders.
On a separate occasion,participants will also undergo a type of scan that has opened the possibility to measure nerve junctions (PET – Positron emission tomography). The PET scan will use a specific molecule (a ‘radiotracer’) which can be labelled with a small amount of radioactivity and can be measured noninvasively when it enters the brain. This specific molecule (11C UCB-J)targets the protein SV2A which is present only in nerve junction sites. Hence this scan will inform us of the number of nerve junctions and will also help us to measure the amount of SV2A acted on by LEV (SV2A is the target of LEV).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Cross-sectional;
You can take part if:
You may not be able to take part if:
All participants: - Age <18 years and >65 years. - Pregnancy or lactating mothers. - Evidence or history of clinically significant hematological,renal,urinary / prostatic,endocrine,dermatological,pulmonary,psychiatric (except for diagnosis indicated in the inclusion criteria for patients),gastrointestinal,cardiovascular or other heart disease,glaucoma,diabetes,hepatic,neurologic (except for diagnosis indicated in the inclusion criteria for ASD patients),head trauma or allergic disease (except for untreated,asymptomatic,seasonal allergies at time of dosing),if any,and in the opinion of the recruiting physician will impair the safety of the subject and/or the scientific integrity of the study. - Anti-epileptic treatment with known interaction with SV2A protein,(e.g. loratidine and quinine) - Known allergy to LEV or to any ingredients of the placebo/LEV formulation used - Significant sustained abnormality in the opinion of the study staff when vital signs are measured at screening or prior to a PET scan. - History of sensitivity to any allergy that in the opinion of the investigator puts them at risk. - Significant history and continuing substance (except nicotine) and/or alcohol dependence. - Participation in a clinical trial and having received an investigational product within the time period mentioned prior to the first day in the current study: 90 days,5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). - Donation of blood or blood products in excess of 500ml within any 60 day period prior to the present study. - Previous inclusion in a research and/or medical protocol involving nuclear medicine,PET or radiological investigations with significant radiation burden (a significant radiation burden being defined as ICRP category IIb or above: No more than 10 mSv in addition to natural background radiation,in 12 months prior to PET imaging in this study,including the dose from this study). - History of,or suffers from,claustrophobia or feels that they will be unable to lie still on his back in the MRI or PET scanner for a period of 2 hours. - Presence of a cardiac pacemaker or other body implants that are ferromagnetic as assessed by a standard pre-MRI questionnaire. Healthy volunteers: - Family history of schizophrenia,bipolar disorder and autism spectrum disorder
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Oliver
Howes
oliver.howes@kcl.ac.uk
Bernard
Bukala
synaptic-connectivity@kcl.ac.uk
Julia
Marcinkowska
synaptic-connectivity@kcl.ac.uk
Julia
Marcinkowska
julia.marcinkowska@kcl.ac.uk
The study is sponsored by King's College London and funded by Medical Research Council (MRC) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 61077
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