A)Dopamine agonists and psychological disorders of hyperprolactinaemia

• Research type

  Research Study

• Full title

  A Prospective Pilot Study to Investigate the Effectiveness of Quinagolide in the Improvement of Psychological Symptoms Associated with Hyperprolactinaemia.

• IRAS ID

  38060

• Contact name

  Mohamed A A M Malik

• Eudract number

  2010-021403-24

• Research summary

  A Prospective Pilot Study to Investigate the Effectiveness of Quinagolide in the Improvement of Psychological Symptoms Associated with Hyperprolactinaemia. The association between primary hyperprolactinaemia (raised level of the hormone Prolactin) and psychological symptoms is well established. Several studies have recognised increased self-reported symptoms of anxiety, hostility and low esteem in patients with hyperprolactinaemia. These symptoms have responded favourably to treatment with Bromocriptine, a drug used to control prolactin level in the blood through its effect on dopamine receptors. Over the last two decades new generation dopamine agonist agents (Cabergoline and Quinagolide) have been in wide clinical use for the treatment of primary hyperprolactinaemia. Both agents have comparable effect to Bromocriptine in controlling serum prolactin, with the added benefit of a better side effect profile. To date there is little known about the effect of these new agents on the psychological symptoms associated with primary hyperprolactinaemia. This RCT pilot study is designed to examine the properties of Quinagolide treatment in modulating the psychological symptoms associated with hyperprolactinaemia, and compare its effectiveness in this aspect to Bromocriptine. The pilot study will form the basis for a multicentre RCT where a larger number of patients will be studied to confirm the observations obtained. The proposed sample for the pilot study is 40 treatment naive patients with hyperprolactinaemia recruited from the endocrine services at Scunthorpe General Hospital and Hull Royal Infirmary, and eighty matched control. The duration of the study is 7 months, which will include a two stage cross over treatment phase intercepted by four weeks washout interval. All patients will be assessed for psychological symptoms at baseline and after each treatment phase using four self-reported health questionnaires.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1002/60

• Date of REC Opinion

  3 Nov 2010

• REC opinion

  Further Information Favourable Opinion