Prospective study of the psychiatric side effects of cabergoline in the treatment of prolactinomas.

Research summary

The relationship between cabergoline treatment of prolactinoma,the most frequently occurring secretory pituitary tumour and psychiatric side effects remains unclear. Understanding the frequency with which these side effects occur,particularly impulse control disorders and the risk factors for their development is important for healthcare professionals to counsel and monitor patients. This is a prospective study using questionnaires at specific timepoints to investigate psychiatric side effects of cabergoline in patients receiving this for the management of prolactinomas. STUDY OBJECTIVES Primary objective To investigate the incidence of impulse control disorder in patients receiving cabergoline treatment for prolactinoma. Secondary objectives To investigate the incidence of anxiety and depression in patients receiving cabergoline treatment for prolactinoma. To identify risk factors for the development of impulse control disorder,anxiety and depression in patients receiving cabergoline treatment for prolactinoma. To evaluate the time course for the development of impulse control disorder,anxiety and depression in patients receiving cabergoline treatment for prolactinoma. STUDY DESIGN This is a prospective cohort study. There will be two groups of patients: Group 1 (patients with a prolactinoma,cabergoline naive with planned cabergoline treatment),Group 2 (patient with a non-functioning pituitary adenoma,normal pituitary function,not requiring cabergoline treatment). There will be 125 patients in each group. Subjects will be adults (>18y). Patients will be enrolled in the study for 18 months. Data collection timepoints will be at baseline,3 months,6 months,12 months and 18 months. Patients who may be eligible for the study will be approached in outpatient clinics or after discussion of their case by their clinical team (eg after a multidisciplinary pituitary meeting) who will have access to their clinical data. Potential participants will be given the patient information sheet. Patients who agree to participate can sign the consent form during that outpatient visit or if they would like more time to consider participating,at a further outpatient review. For Group 1,blood tests will be collected as part of routine clinical care (eg by hospital phlebotomy) that prolactinoma patients receive. Collection of questionnaire data,which is not part of routine clinical care,will be performed at the specific timepoints. For Group 2,blood tests at timepoints after baseline will be collected as part of the study organised by the clinical team (eg blood tests at hospital phlebotomy). Collection of questionnaire data (three questionnaires at each timepoint) will be performed at the specific timepoints. The three questionnaires will take approximately 15-20 minutes in total to complete. Questionnaires will be completed electronically either during the clinic visit or may be completed remotely. Blood tests will be analysed by the clinical biochemistry laboratories at the participating centres and will not be stored. Approximately 5mls blood will be collected for each timepoint (maximum 15mls per timepoint). DATA COLLECTION TIMEPOINT 1 Baseline demographic and clinical data will be recorded (any imaging and blood tests will be organised by clinical team as part of routine clinical care). For Group 1 (prolactinoma patients),this timepoint is prior to starting cabergoline treatment. Baseline questionnaires: Patient Health Questionnaire-9 (PHQ-9) - to screen for depression Generalised Anxiety Disorder 7 (GAD7) - to screen for generalised anxiety disorder Modified Minnesota Impulsive Disorders Interview (MIDI) – to screen for impulse control disorder. SUBSEQUENT DATA COLLECTION TIMEPOINTS At each subsequent timepoint,patients will have a blood test for reproductive axis hormones and will complete PHQ-9,GAD-7 and MIDI questionnaires. Remaining timepoints are (from baseline,each timepoint can be +/- one month from specified time point): TIMEPOINT 2 (3 months) TIMEPOINT 3 (6 months) TIMEPOINT 4 (12 months) TIMEPOINT 5 (18 months) Outcomes will be compared in the cabergoline-treated group at each timepoint with baseline data. In addition,outcomes in the cabergoline group will be compared with those in the non-functioning pituitary adenoma group. OUTCOME MEASURES Primary outcome measure New onset of impulse control disorder using the MIDI questionnaire. Secondary outcome measures: New onset depression using the PHQ-9 questionnaire and/or anxiety using the GAD7 questionnaire. Changes in reproductive axis hormones (eg prolactin) associated with the development of psychiatric side effects with cabergoline treatment. Time course for the development of psychiatric side effects with cabergoline treatment. The primary investigator will not be accessing patient notes from sites outside of their own (Imperial Healthcare NHS Trust). Only clinical teams caring for these patients will access their clinical details. Pseudoanonymised data including reproductive hormone results,pituitary MRI results and questionnaire data will be shared between the clinical team at the respective study site and the PI (Professor Niamh Martin).

Principal Investigator

Dr Aparna Pal

Contact us

Email: diabetes.research1@ouh.nhs.uk

IRAS number

338869