Psychiatric side effects of cabergoline in prolactinomas
Research type
Research Study
Full title
Prospective study of the psychiatric side effects of cabergoline in the treatment of prolactinomas.
IRAS ID
338869
Contact name
Niamh Martin
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
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.REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0185
Date of REC Opinion
9 Sep 2024
REC opinion
Further Information Favourable Opinion