BRC Trials Office

NIHR Maudsley BRC Trials Office: a central contact point for clinical trials in psychosis

Clinical trials look at new ways to prevent, detect, or treat a disease and are at the heart of all medical advances. The clinical trials developed by the NIHR Maudsley Biomedical Research Centre (BRC) are the final step in the development of new treatments for mental health conditions.

Like in any other branch of medicine, participation in research might be a unique opportunity for people that suffer mental health conditions to progress in their recovery.

Despite our long history in research, patients and their carers might be unaware that numerous ongoing research projects are available and may not know who to contact.

Our strategy focuses on three main issues:

  • Identify biological factors that cause psychosis
  • Design new treatments to improve the quality of life of patients that still experience symptoms despite taking medications
  • Develop treatments that involve less possible side effects. 

The BRC Trials Office is here to make the connection between patients, carers and key-workers with researchers. We welcome contact from South London and Maudsley NHS Foundation Trust (SLaM) staff and patients to discuss current studies and to clarify what is involved for people who want to take part.

Contact Details

We are located in the Department of Psychosis Studies at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN).

Phone: 0207 848 0057
Email: BRCtrials@kcl.ac.uk
BRC Trials Office Team: Alice Egerton, Paul Morrison

The NIHR Biomedical Research Centre and Dementia Unit (BRC/U) at South London and Maudsley NHS Foundation Trust (SLaM) and the Institute of Psychiatry, Psychology and Neuroscience (IoPPN), King’s College London is at the forefront of research into new anti-psychotic medications.

The development of new treatments is of major importance: current treatments mainly target positive symptoms such as delusions and hallucination but have little effect on other aspects of the illness such as cognitive impairment or social functioning. For some patients  these medications are very effective, but for others the side effects can impact heavily on a person’s day-to-day activities.

The only way to find out if a new treatment is effective is through a trial.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

They have the satisfaction of knowing that they have contributed to knowledge which could potentially impact on future practices all over the world. Patients are also financially reimbursed for giving up their time to take part.

We know that patients who take part in a clinical trial show improvements in their recovery, regardless of whether they are given the active trial drug or a placebo.

Clinical trials offer hope for many people and an opportunity to help find better treatments for others in the future.

All our studies are approved by:

  1. The National Research Ethics Committee (NRES)
  2. A risk assessment committee
  3. The sponsor of the study
  4. The Medicines and Healthcare Regulatory Authority (MHRA) and
  5. The Psychosis CAG

Safety concerns are assessed as part of a prolonged process to gain approvals to carry out a trial. Once a trial begins, it is carefully monitored by the sponsor to make sure it is conducted according to Good Clinical Practice. If any safety concerns arise during the course of a study, these are acted upon according to clear guidelines.

OPTiMiSE project – (Funded by the European Union)

The main objective is to find the best way to use medicines currently available to treat hallucinations or delusions (psychotic symptoms).

Blood tests and brain scans will be used to investigate whether it is possible to predict which medication will work best for an individual patient.

Benefits of participating include: close monitoring of treatment and recovery; swift implementation of other treatment options if you do not recover within a set time frame and reimbursement for your time.

For full information on the study please contact BRCtrials@kcl.ac.uk


CBD_VR2- cannabidiol tablets

This study targets young people who have just started to experience some symptoms of perceptual abnormalities or paranoid thinking and might report changes in their normal drive for daily activities and social interests. These are just some of the features of the so called “at risk mental state”, a syndrome that might indicate a vulnerability to develop psychotic disorders. Intervention in this phase is crucial for prevention of more severe illnesses, however there is no specific pharmacological treatment addressing it.

The study involves the administration of Cannabidiol (CBD) a natural compound derived from the cannabis plant, that has no psycho-active effect while presenting several neuro-protective features. In particular the study aims at understanding the effect of CBD in helping people in “at risk mental state” controlling anxiety and paranoid thinking.

For full information on the study please contact BRCtrials@kcl.ac.uk

‘Negative symptoms’ can include but are not limited to:

  • loss of drive and motivation
  • lack of interest in others
  • less capacity to feel emotion
  • persistent boredom
  • cognitive impairment

MinocyclineStudy– (Funded by the National Institute of Health Research and the Medical Research Council)

The main objective is to find out if negative symptoms improve after the antibiotic Minocycline is added to the existing treatment package.

Brain scanning is involved in the study to investigate how the drug is working on the brain.

Possible benefits of taking part include, close monitoring and assessment of mental health, and reimbursement for your time.

For full information on the study please contact BRCtrials@kcl.ac.uk


Nitric Oxide : The effect of nitric oxide on spatial working memory in patients with schizophrenia

Nitric oxide (NO) is a gaseous molecule which seem to have a an effect on poor cognitive performance in schizophrenia.

In particular the study aims at understanding the molecule  effect on improving spatial working memory task, a key cognitive deficit in schizophrenia.

The study involve patients with a diagnosis of schizophrenia or schizoaffective disorder, currently experiencing an exacerbation of symptoms and currently taking antipsychotics.

For full information on the study please contact BRCtrials@kcl.ac.uk


Alpha-7 Nicotinic Acetylcholine Receptor Agonist (EVP-6124) as a treatment to improve mental function in Schizophrenia

The aim of the investigation is to improve cognitive performance of people suffering from schizophrenia, through the administration of a drug that acts as an agonist of Nicotine receptors. Cognitive impairment is a core feature of Schizophrenia, being responsible for the disabling impact of the illness. Standard treatment with Anti Psychotic does not tackle this aspect of the disorder and new treatments need to be introduced to this end.

This study recruits people with a diagnoses of Schizophrenia that are currently stable on treatment with Atypical Antipsychotic, between the age of 18 and 50.

For full information on the study please contact BRCtrials@kcl.ac.uk

CBD- Add in: Cannabidiol as an add-on therapy in treatment refractory psychotic disorders

The study involves the administration of Cannabidiol (CBD) a natural compound derived from the cannabis plant, that has no psycho-active effect while presenting several neuro-protective features.

This study aims at determining whether the addition of the molecule CBD leads to improvement in the severity of core psychotic symptom, in patients experiencing their first psychotic episode who have failed to recover despite treatment with at least one standard anti-psychotic drug.

Time is reimbursed and transfers arranged.

For full information on the study please contact BRCtrials@kcl.ac.uk


TRIC study: Clozapine in Treatment Resistant Schizophrenia


Clozapine is the most powerful antipsychotic medication and it seems to be particularly effective for those people who are still experiencing hallucination and delusions despite trying different medications. The reason why some people do not respond to standard treatment for antipsychotic is still under investigation and seems to be linked to an imbalance in the production of certain neurotransmitters in the brain.

This study involves people who are prescribed Clozapine after at least two other attempts with antipsychotic have failed and aims at understanding the biological processes responsible for antipsychotic treatment resistance. More over the study is designed to:

  1. predict which patients are most likely to respond well to clozapine
  2. predict which patients are most likely to experience side effects of clozapine
  3. better understand the biological basis of clozapine response and side effects, in order to ultimately aid development of new treatments

Participation involves the administration of a Magnetic Resonance (MRI) scan and patients are reimbursed for their time.

For full information on the study please contact BRCtrials@kcl.ac.uk