We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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.
Niamh
Martin
n.martin@imperial.ac.uk
Niamh
Martin
n.martin@imperial.ac.uk
Niamh
Martin
n.martin@imperial.ac.uk
Disorders of adult personality and behaviourBenign neoplasms
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. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The pituitary gland,at the base of the brain,produces essential hormones. Prolactinomas are benign (non-cancerous) pituitary tumours producing too much of the hormone prolactin,frequently causing irregular periods,reduced libido and infertility.
Cabergoline is a tablet medication which successfully treats prolactinomas without the need for surgery. Dopamine regulates prolactin release from the pituitary gland. Cabergoline binds to specific dopamine receptors on prolactinoma cells,reducing prolactin and shrinking the tumour. It is the first-line treatment in the UK for prolactinomas.
Dopamine is also involved in reward and motivation pathways in the brain. Patients receiving cabergoline for prolactinomas may be at risk of impulse control disorders (ICDs). These are characterised by repetitive behaviours despite negative consequences,often with a lack of control over the behaviour eg compulsive gambling. ICDs are thought to arise from effects of cabergoline on dopamine reward and motivation pathways in the brain. Cabergoline may also predispose patients to depression and anxiety. Since development of these psychiatric side effects can have devastating effects for patients,it is essential that we understand more about the potential side effects of cabergoline when used to treat prolactinomas.
This is a multi-centre,prospective study using questionnaires to assess depression,anxiety and impulsivity. Patients with a newly diagnosed prolactinoma will complete questionnaires before starting cabergoline (baseline) and then at subsequent timepoints. Similarly,these questionnaires will also be completed,at the same timepoints,by patients with a pituitary tumour not making too much of any pituitary hormone who will not be receiving cabergoline. Those patients where questionnaires highlight a potential ICD will be reviewed by a psychiatrist to explore in more detail how they are feeling. We will compare the questionnaire responses in each group to baseline responses and between both groups.
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: Cohort study;
You can take part if:
You may not be able to take part if:
Patients who are unable to read and understand the study questionnaires will not be able to participate in the study. Patients who are pregnant or planning a pregnancy will be excluded (often cabergoline is discontinued in pregnancy in patients with a prolactinoma). Breastfeeding patients cannot participate (cabergoline inhibits lactation and affects pituitary hormone function). Substance dependence/misuse (mood disturbance and impulsivity are strongly associated with substance misuse disorders). Existing impulse control disorder/psychotic disorder/bipolar affective disorder/personality disorder/traumatic brain injury with challenging behaviour (clinical team may decide to treat with cabergoline,these can all potentially confound data interpretation). Severe anxiety or depression (as assessed by PHQ-9 and GAD-7).
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Niamh
Martin
n.martin@imperial.ac.uk
Niamh
Martin
n.martin@imperial.ac.uk
Niamh
Martin
n.martin@imperial.ac.uk
The study is sponsored by Imperial College of Science, Technology and Medicine and funded by SOCIETY FOR ENDOCRINOLOGY .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 65714
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
