by Dr. Lisa Douglas, Senior Clinical Studies Officer at Cheshire & Wirral Partnership NHS Foundation Trust
14th January 2025
Today I am with Clinical Studies Officer Sophie Evans at Bowmere in-patient unit visiting a service user who has been referred to us for the PPiP2 (Prevalence of Pathogenic antibodies in Psychosis) study. PPiP2 is a research study led by the University of Oxford. It is investigating the hypothesis that around 8% of patients who are diagnosed with a psychotic illness actually have an auto-immune disorder which is causing their symptoms. The symptoms of this auto-immune disorder are very similar to those of psychosis and schizophrenia including hallucinations, delusions, aggression, cognitive difficulties, and paranoia. The PPiP2 auto-immune disorder is diagnosed through blood tests which are looking for the presence of pathogenic neuronal cell surface antibodies (NMDA, LGI1, GABA-A and others). Patients must be actively experiencing psychotic symptoms when these study blood tests are performed as it at this point when pathogenic auto-immune antibodies are most numerous, active and detectable. Sophie is lead Clinical Studies Officers for the PPiP2 study and once every week she visits patients at Bowmere to see if they would like to be tested by the PPiP2 study. It is important to do this as these patients are at the stage in their condition where antibodies are most evident. Our patient today has signed a consent form to confirm they fully understand the PPiP2 study. Blood samples are now taken and immediately sent to the Department of Psychiatry Laboratories at the University of Oxford. The labs at Oxford are one of a handful of centres in the UK which have the capability to test for these particular pathogenic antibodies.
Lead CSO for PPiP2 in CWP
CWP has taken part in the PPiP2 project since 2016 and during that time 177 patients with acute psychosis have had blood samples taken as part of the project. Of these, nine patients have tested positive for pathogenic antibodies. As a result, the course of their treatment has been modified to include immuno-suppressants (in order to reduce the auto-immune response), steroids (to reduce the inflammatory response) and plasma exchange (to clear the inflammation). These patients are also offered a place in a follow-on clinical trial (SINAPPS) which is examining a new monoclonal antibody treatment specific to this autoimmune disorder. If the hypothesis that 8% of patients with psychotic symptoms have an auto-immune condition is proved correct, the implications for patients and mental health services in terms of diagnosis, treatment, social and health service costs will be highly significant. PPiP2 is an example of how research is developing knowledge and challenging current thinking about the biological and psychological basis of mental illnesses and how these can be treated.
To learn more about the PPiP2 and SINAPPS studies contact us at cwp.
4th December 2024
What is a Clinical Studies Officer?
Some of the most frequently asked questions we hear from staff and patients is ‘what is a Clinical Studies Officer and what do they do?’.
Clinical Studies Officers (CSOs) were created by the National Institute of Health Research (NIHR) in 2005 to help recruit patients to clinical research in the NHS and in universities. Before that time, many studies and trials would fail to recruit enough patients because doctors, nurses and clinicians did not have time in their busy clinical work to also spend on research. This meant that NHS patients often missed out on the opportunity to take part in clinical research testing new and innovative treatments. It must be remembered that every new medication and treatment used by the NHS has had to go through thousands of hours or rigorous research and safety testing before it can be used to treat to patients. This costs many millions of pounds per year but has to be done to ensure each new drug and therapy is safe and effective for patient use. Therefore, recruitment to clinical research is vital if new and better treatments are to be made available to NHS patients. This is why the role of the CSO was set up by the NIHR. Originally their task was to visit hospitals, health clinics, community teams, patient support groups and charities to promote research, to provide information on specific studies and to get patients started on their research journey.
Over the past eighteen years the role of the CSO has transformed from one solely based on patient recruitment to that of a multi-skilled research practitioner. CSOs are now qualified and able to undertake physical and mental health assessments, tissue sampling and processing, data collection and data analysis. In CWP, CSOs are now able to run every type of clinical trial and mental health study from end to end – from set-up to publication. They do all this whilst following strict ethical standards and medical guidelines to ensure patient safety is paramount.
There are now four CSOs in CWP coming from a variety of backgrounds including psychiatric and general nursing, psychology and public health. Our CSOs have recruited thousands of CWP patients to clinical studies and trials over nearly two decades. Although CSOs perform many different tasks, the main aim of their role remains embedded in the NHS Constitution. This promises that “patients have a right to know about and take part in research which is applicable to them.” - CSOs make this happen.
8th November 2024
Today was an early start in the CWP Research clinic at Upton Lea as it is Visit 3 (week 12) in our CONNEX-X clinic trial. CONNEX-X is a randomised, placebo-controlled clinical trial of Iclepertin as a treatment for negative symptoms and cognitive deficits in schizophrenia. Clinic visits for pharmaceutical trials have many different members of staff involved so everything has to be regimented to make sure all staff and systems come together at the right time.
9am patient arrives. Patient is asked about any adverse events, new medications, medical interventions or mental health issues since their last visit.
9.30am blood samples are taken from patient. These have to stand for 60 minutes and are then spun by Kelly and Sophie using our refrigerated centrifuge in the Research Lab next door. These blood samples check that the patient is physically well and also look at the levels of the study medication in their system. We are also looking out for anything like drug-induced liver injury.
9.45am Our study physician arrives. The patient is given a thorough medical examination and an ECG. This is to ensure that there have been no adverse reactions or events since the last study visit. Particular attention is paid to the patient’s vision as Iclepertin can cause visual disturbances.
10.30am Blood samples are centrifuged, serum is extracted, and blood slides are created. These are carefully and safely packed in dry ice at
10.35am Meanwhile our study physician is satisfied the patient is well enough to continue the trial and a prescription for a new batch of trial medication is taken to the Clinical Trials Pharmacy at the Countess of Chester hospital.
11am Patient is given their new batch of study medication and their next clinic appoint is arranged for December.
11.30am ECG is signed off by study physician and is then uploaded to ERT Clario website where it will be examined by a cardiologist in the United States. Their report should be available in about one week.
12pm Courier arrives to pick up blood samples. All paperwork is checked before samples are driven to Manchester airport for flight to Geneva this afternoon. These will arrive at the central labs tonight and will be immediately analysed. A full blood safety report should be available when we arrive for work on Monday morning. The study Principal Investigator Dr. Tremblay will examine these results looking for any emerging physical health issues.
12.30pm All data and information collected today is now recorded in iMedidata which is the Trial on-line database. This will be checked by medical safety monitors based in Germany.
12.45pm. Finally, clean and tidy up lab and clinic room ready for next patient visit.